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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000648194 | |||
| NCI-2011-01948 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. After completion of study therapy, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalated Radiation Therapy Alone | Active Comparator | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. |
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| Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Experimental | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicalutamide | Drug | Administered orally at a dose of one 50 mg tablet per day, beginning within (before, same day as, or after) 10 days of the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive (Overall Survival) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biochemical Failure | Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive (Overall Survival) by Ethnicity | NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. |
Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below:
No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration.
Zubrod Performance Status 0-1
Age ≥ 18
Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria:
Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for this trial.
Patients with all three intermediate risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)
Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
Use of finasteride within 30 days prior to registration
Use of dutasteride within 90 days prior to registration
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted.
Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
Severe, active co-morbidity, defined as follows:
Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro A. Martinez, MD, FACR | 21st Century Oncology - Michigan Institute for Radiation Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Fairbanks Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37104748 | Derived | Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, Movsas B, Elshaikh M, Citrin D, Hershatter B, Michalski JM, Efstathiou JA, Currey A, Kavadi VS, Cury FL, Lock M, Raben A, Seaward SA, El-Gayed A, Rodgers JP, Sandler HM. Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial. J Clin Oncol. 2023 Jun 10;41(17):3203-3216. doi: 10.1200/JCO.22.02390. Epub 2023 Apr 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-Escalated Radiation Therapy Alone | Radiation therapy consists of 79.2 Gy external beam radiotherapy (EBRT) only or 45 Gy EBRT followed by low dose rate (LDR) or high-dose rate (HDR) brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. |
| FG001 | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2015 |
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| flutamide | Drug | Administered orally at a dose of 250 mg (two 125-mg capsules) three times a day for a total daily dose of 750 mg, beginning within (before, same day as, or after) 10 days of with the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months. |
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| LHRH agonist (antagonist) therapy | Drug | LHRH agonist (antagonist) therapy consists of leuprolide, goserelin, buserelin, triptorelin, or degarelix. The manufacturer's instructions should be followed. The first administration occurs with the start of anti-androgen treatment 8 weeks prior to the start of RT. The total duration of LHRH agonist (antagonist) therapy is 6 months. |
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| Dose-Escalated Radiation Therapy | Radiation | External beam radiotherapy (EBRT) as 3D Conformal Radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT). Brachytherapy is optional, at the discretion of the treating physician. Patients treated entirely via EBRT receive 79.2 Gy delivered in 1.8 Gy fractions. Patients who receive brachytherapy as a component of their RT receive 45 Gy EBRT in 1.8 Gy fractions. Low-dose brachytherapy boost occurs following the EBRT portion of treatment no more than 4 weeks following its completion.High-dose rate brachytherapy boost is delivered in 2 fractions separated by a minimum time span of 6 hours and the implant(s) may be performed during the EBRT portion of the treatment or within 1 week prior to its initiation or following its completion. |
|
| From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants With Local Recurrence | Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence [this date is used] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants With Regional Recurrence | Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure. | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years. |
| Percentage of Participants With Distant Metastasis | Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality) | Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT) | Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Number of Participants With Acute Adverse Events | Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. |
| Percentage of Participants With Late Grade 3+ Adverse Events | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here. |
| Percentage of Participants Failed (Freedom From Failure) | Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Domain Score | The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year. | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Quality Adjusted Life Years (QALYs) | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
| Correlation Between PROMIS Fatigue Score Change and Plasma Cytokine Change | From date of randomization to 3 weeks from start of RT. |
| From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Percentage of Participants Alive (Overall Survival) by Race | NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
| Fairbanks |
| Alaska |
| 99701 |
| United States |
| Arizona Center for Cancer Care-Peoria | Peoria | Arizona | 85381 | United States |
| Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
| 21st Century Oncology-Scottsdale | Scottsdale | Arizona | 85251 | United States |
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
| Arizona Oncology Services Foundation | Scottsdale | Arizona | 85260 | United States |
| Arizona Oncology Associates-West Orange Grove | Tucson | Arizona | 85704 | United States |
| Mercy Cancer Center-Hot Springs | Hot Springs | Arkansas | 71913 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | 95603 | United States |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | 94704 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| Enloe Medical Center | Chico | California | 95926 | United States |
| 21st Century Oncology - El Segundo | El Segundo | California | 90245 | United States |
| Fresno Cancer Center | Fresno | California | 93720 | United States |
| Saint Agnes Medical Center | Fresno | California | 93720 | United States |
| Marin General Hospital | Greenbrae | California | 94904 | United States |
| Veterans Administration Long Beach Medical Center | Long Beach | California | 90822 | United States |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Memorial Medical Center | Modesto | California | 95355 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Desert Regional Medical Center | Palm Springs | California | 92262 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94304 | United States |
| Feather River Cancer Center | Paradise | California | 95969 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cardova | California | 95670 | United States |
| Kaiser Permanente-Redwood City | Redwood City | California | 94063 | United States |
| Kaiser Permanente-Richmond | Richmond | California | 94801 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | United States |
| Kaiser Permanente-Roseville | Roseville | California | 95661 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | United States |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | 95678 | United States |
| Sutter General Hospital | Sacramento | California | 95816 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Mercy General Hospital Radiation Oncology Center | Sacramento | California | 95819 | United States |
| Kaiser Permanente-South Sacramento | Sacramento | California | 95823 | United States |
| South Sacramento Cancer Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente - Sacramento | Sacramento | California | 95825 | United States |
| University of California San Diego | San Diego | California | 92103 | United States |
| Kaiser Permanente-San Francisco | San Francisco | California | 94115 | United States |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | United States |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | 94118 | United States |
| Kaiser Permanente-Santa Teresa-San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente San Leandro | San Leandro | California | 94577 | United States |
| Kaiser Permanente-San Rafael | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente-Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-Stockton | Stockton | California | 95210 | United States |
| David Grant United States Air Force Medical Center | Travis AFB | California | 94535-1800 | United States |
| Tahoe Forest Cancer Center | Truckee | California | 96161 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | 95687 | United States |
| Sutter Solano Medical Center/Cancer Center | Vallejo | California | 94589 | United States |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| The Shaw Regional Cancer Center | Edwards | Colorado | 81632 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81502 | United States |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Yale-New Haven Hospital Saint Raphael Campus | Hew Haven | Connecticut | 06511 | United States |
| Midstate Medical Center | Meriden | Connecticut | 06451 | United States |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| Florida Hospital Kissimmee | Kissimmee | Florida | 34744 | United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | United States |
| The Watson Clinic | Lakeland | Florida | 33805 | United States |
| Jackson Memorial Hospital-Holtz Children's Hospital | Miami | Florida | 33136 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| South Miami Hospital | Miami | Florida | 33143 | United States |
| Florida Hospital Orlando | Orlando | Florida | 32803 | United States |
| Bay Medical Center | Panama City | Florida | 32401 | United States |
| James A. Haley Veterans Affairs Hospital | Tampa | Florida | 33612 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| John B Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Northside Hospital-Forsyth | Cumming | Georgia | 30041 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Piedmont Fayette Hospital | Fayetteville | Georgia | 30214 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Memorial University Medical Center | Savannah | Georgia | 31404 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Saint Anthony's Health | Alton | Illinois | 62002 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612-3785 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Hines Veterans Administration Hospital | Hines | Illinois | 60141 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria | Illinois | 61615-7827 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | 61114 | United States |
| Saint John's Hospital | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| Memorial and Saint Elizabeth's Health Care Services LLP | Swansea | Illinois | 62226 | United States |
| Saint Vincent Anderson Regional Hospital/Cancer Center | Anderson | Indiana | 46016 | United States |
| IU Health West Hospital | Avon | Indiana | 46123 | United States |
| IU Health Bloomington | Bloomington | Indiana | 47403 | United States |
| Radiation Oncology Associates PC | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| IU Health Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Richard L. Roudebush Veterans Affairs Medical Center | Indianapolis | Indiana | 46202 | United States |
| IU Health Central Indiana Cancer Centers-East | Indianapolis | Indiana | 46219 | United States |
| McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa | 50010 | United States |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Iowa Oncology Research Association CCOP | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | 50314 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Kansas City Cancer Centers-Southwest | Overland Park | Kansas | 66210 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates In Womens Health | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Main Office | Wichita | Kansas | 67214 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Wichita CCOP | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| The James Graham Brown Cancer Center at University of Louisville | Louisville | Kentucky | 40202 | United States |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | 42303 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Central Maine Medical Center | Lewiston | Maine | 04240 | United States |
| Maine Medical Center- Scarborough Campus | Scarborough | Maine | 04074 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| Upper Chesapeake Medical Center | Bel Air | Maryland | 21015 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | 21044 | United States |
| Tate Cancer Center | Glen Burnie | Maryland | 21061 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Mass General/North Shore Cancer Center | Danvers | Massachusetts | 01923 | United States |
| Saint Anne's Hospital | Fall River | Massachusetts | 02721 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Berkshire Hematology Oncology PC | Pittsfield | Massachusetts | 01201 | United States |
| Beth Israel Deaconess Hospital-Plymouth | Plymouth | Massachusetts | 02360 | United States |
| D'Amour Center for Cancer Care | Springfield | Massachusetts | 01107 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Saint Vincent Hospital/Reliant Medical Group | Worcester | Massachusetts | 01608 | United States |
| Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Veteran's Administration Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106-0995 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| McLaren-Bay Region | Bay City | Michigan | 48708 | United States |
| Henry Ford Macomb Hospital | Clinton Township | Michigan | 48038 | United States |
| Huron Valley-Sinai Hospital | Commerce | Michigan | 48382 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Green Bay Oncology - Escanaba | Escanaba | Michigan | 49431 | United States |
| Botsford General Hospital | Farmington | Michigan | 48334 | United States |
| 21st Century Oncology-Farmington Hills | Farmington Hills | Michigan | 48334 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | 48532 | United States |
| McLaren-Flint | Flint | Michigan | 48532 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan | 49801 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| Great Lakes Cancer Institute-Lapeer Campus | Lapeer | Michigan | 48446 | United States |
| McLaren-Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren-Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| Northern Michigan Regional Hospital | Petoskey | Michigan | 49770 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Port Huron | Port Huron | Michigan | 48060 | United States |
| Crittenton Hospital | Rochester | Michigan | 48307 | United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Saint Mary's of Michigan | Saginaw | Michigan | 48601 | United States |
| Downriver Center for Oncology | Trenton | Michigan | 48183 | United States |
| 21st Century Oncology-Troy | Troy | Michigan | 48098 | United States |
| William Beaumont Hospital - Troy | Troy | Michigan | 48098 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States |
| Sanford Clinic North-Bemidgi | Bemidji | Minnesota | 56601 | United States |
| Miller-Dwan Hospital | Duluth | Minnesota | 55805 | United States |
| Saint Luke's Hospital of Duluth | Duluth | Minnesota | 55805 | United States |
| Fairview-Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center - Saint Peters | City of Saint Peters | Missouri | 63376 | United States |
| Mercy Hospital-Joplin | Joplin | Missouri | 64804 | United States |
| Kansas City Cancer Center - South | Kansas City | Missouri | 64131 | United States |
| Kansas City Cancer Centers - North | Kansas City | Missouri | 64154 | United States |
| Kansas City Cancer Center-Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Phelps County Regional Medical Center | Rolla | Missouri | 65401 | United States |
| Cancer Research for the Ozarks NCORP | Springfield | Missouri | 65804 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Barnes-Jewish West County Hospital | St Louis | Missouri | 63141 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Saint Louis-Cape Girardeau CCOP | St Louis | Missouri | 63141 | United States |
| Montana Cancer Consortium CCOP | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59107 | United States |
| Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Saint Elizabeth Regional Medical Center | Lincoln | Nebraska | 68510 | United States |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Alegent Health Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Alegent Health Lakeside Hospital | Omaha | Nebraska | 68130 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Concord Hospital | Concord | New Hampshire | 03301 | United States |
| Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| Cheshire Medical Center-Dartmouth-Hitchcock Keene | Keene | New Hampshire | 03431 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Ocean Medical Center | Brick | New Jersey | 08724 | United States |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | United States |
| Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey | 07018-1095 | United States |
| CentraState Medical Center | Freehold | New Jersey | 07728 | United States |
| Princeton Radiation Oncology Center | Monroe | New Jersey | 08831 | United States |
| Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly | New Jersey | 08060 | United States |
| Jersey Shore Medical Center | Neptune City | New Jersey | 07753 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| UMDNJ - New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| The Medical Center At Princeton | Princeton | New Jersey | 08540-3298 | United States |
| Riverview Medical Center/Booker Cancer Center | Red Bank | New Jersey | 07701 | United States |
| Sparta Cancer Treatment Center | Sparta | New Jersey | 07871 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| MD Anderson Cancer Center at Cooper-Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Virtua West Jersey Hospital Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Prostate Cancer Center of New Jersey | West Orange | New Jersey | 07052 | United States |
| Lovelace Medical Center-Downtown | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Radiation Oncology Associates | Albuquerque | New Mexico | 87109 | United States |
| Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | 88011 | United States |
| New York Oncology Hematology PC - Albany | Albany | New York | 12206 | United States |
| Saint Peters Hospital-Albany | Albany | New York | 12208 | United States |
| Southside Hospital | Bay Shore | New York | 11706 | United States |
| Lourdes Hospital | Binghamton | New York | 13905 | United States |
| State University of New York Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus | Brooklyn | New York | 11209 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Sands Cancer Center | Canandiaqua | New York | 14424 | United States |
| Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | 14905 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| North Shore-LIJ Health System NCORP | Manhasset | New York | 11030 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| North Shore-LIJ Health System/Center for Advanced Medicine | New Hyde Park | New York | 11040 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Hudson Valley Oncology Associates | Poughkeepsie | New York | 12601 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University Radiation Oncology | Rochester | New York | 14626 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Randolph Hospital | Asheboro | North Carolina | 27203 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | United States |
| The Coleman Radiation Center-Carteret General Hospital | Morehead City | North Carolina | 28557 | United States |
| CarolinaEast Health System-Medical Center | New Bern | North Carolina | 28560 | United States |
| Duke Cancer Institute Macon Pond | Raleigh | North Carolina | 27607 | United States |
| Rex Cancer Center | Raleigh | North Carolina | 27607 | United States |
| South Atlantic Radiation Oncology | Supply | North Carolina | 28462 | United States |
| Coastal Carolina Radiation Oncology | Wilmington | North Carolina | 28401 | United States |
| New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington | North Carolina | 28401 | United States |
| Southeast Cancer Consortium-Upstate NCORP | Winston-Salem | North Carolina | 27104 | United States |
| Mid Dakota Clinic | Bismarck | North Dakota | 58501 | United States |
| Saint Alexius Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58122 | United States |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | United States |
| Trinity Cancer Care Center | Minot | North Dakota | 58701 | United States |
| Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio | 44304 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Barberton Hospital | Barberton | Ohio | 44203 | United States |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | United States |
| Geaugra Hospital | Chardon | Ohio | 44024 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Columbus CCOP | Columbus | Ohio | 43215 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | United States |
| Doctors Hospital | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Mercy Cancer Center-Elyria | Elyria | Ohio | 44035 | United States |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio | 43537 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| Summa Health Center at Lake Medina | Medina | Ohio | 44256 | United States |
| Lake University Ireland Cancer Center | Mentor | Ohio | 44060 | United States |
| Southwest General Health Center Ireland Cancer Center | Middleburg Heights | Ohio | 44130 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Saint Charles Hospital | Oregon | Ohio | 43616 | United States |
| University Hospitals Parma Medical Center | Parma | Ohio | 44129 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Robinson Radiation Oncology | Ravenna | Ohio | 44266 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| Ireland Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| North Coast Cancer Care | Sandusky | Ohio | 44870 | United States |
| Flower Hospital | Sylvania | Ohio | 43560 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Mercy Saint Anne Hospital | Toledo | Ohio | 43623 | United States |
| University Pointe | West Chester | Ohio | 45069 | United States |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Cleveland Clinic Wooster Specialty Center | Wooster | Ohio | 44691 | United States |
| Wright-Patterson Medical Center | Wright-Patterson AFB | Ohio | 45433-5529 | United States |
| Genesis HealthCare System | Zanesville | Ohio | 43701 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Willamette Valley Cancer Center | Eugene | Oregon | 97401 | United States |
| Three Rivers Community Hospital | Grants Pass | Oregon | 97527 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Asante Health System | Medford | Oregon | 97504 | United States |
| Providence Medford Medical Center | Medford | Oregon | 97504 | United States |
| Rogue Valley Medical Center | Medford | Oregon | 97504 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Western Oncology Research Consortium | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | 18015 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Mercy Fitzgerald Hospital | Darby | Pennsylvania | 19023-1291 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| The Regional Cancer Center | Erie | Pennsylvania | 16505 | United States |
| Fox Chase Cancer Center Buckingham | Furlong | Pennsylvania | 18925 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Cherry Tree Cancer Center | Hanover | Pennsylvania | 17331 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Academic Urology Prostate Center | King of Prussia | Pennsylvania | 19406 | United States |
| Saint Mary Medical and Regional Cancer Center | Langhorne | Pennsylvania | 19047 | United States |
| Upper Delaware Valley Cancer Center | Milford | Pennsylvania | 18337 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Mainline Health CCOP | Wynnewood | Pennsylvania | 19096 | United States |
| WellSpan Health-York Hospital | York | Pennsylvania | 17405 | United States |
| AnMed Health Hospital | Anderson | South Carolina | 29621 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | 29615 | United States |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| Greenville Health System Cancer Institute-Greer | Greer | South Carolina | 29650 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Carolina Regional Cancer Center | Myrtle Beach | South Carolina | 29577 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee | 37660 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Blount Memorial Hospital | Maryville | Tennessee | 37804 | United States |
| Texas Oncology-Arlington South | Arlington | Texas | 76014 | United States |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | United States |
| Texas Oncology - Central Austin Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology - South Austin Cancer Center | Austin | Texas | 78745 | United States |
| Texas Oncology Bedford | Bedford | Texas | 76022 | United States |
| Texas Cancer Center - Medical City Dallas | Dallas | Texas | 75230 | United States |
| Texas Oncology Methodist Charlton Cancer Center | Dallas | Texas | 75237 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Texas Oncology-Denton South | Denton | Texas | 76210 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| The Klabzuba Cancer Center | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| Texas Oncology - Lewisville | Lewisville | Texas | 75067 | United States |
| Texas Oncology-Longview Cancer Center | Longview | Texas | 75601 | United States |
| West Texas Cancer Center | Odessa | Texas | 79761 | United States |
| Texas Oncology-Seton Williamson | Round Rock | Texas | 78665 | United States |
| Texas Oncology - Round Rock Cancer Center | Round Rock | Texas | 78681 | United States |
| Texas Cancer Center-Sherman | Sherman | Texas | 75090 | United States |
| Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas | 77479 | United States |
| Texas Oncology-Wichita Falls Texoma Cancer Center | Wichita Falls | Texas | 76310 | United States |
| Sandra L Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| Southwestern Vermont Medical Center | Bennington | Vermont | 05201 | United States |
| Rutland Regional Medical Center | Rutland | Vermont | 05701 | United States |
| Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | 05819 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Augusta Health Cancer Center | Fishersville | Virginia | 22939 | United States |
| Sentara Cancer Institute at Sentara CarePlex Hospital | Hampton | Virginia | 23666 | United States |
| Sentara Rockingham Memorial Hospital Hahn Cancer Center | Harrisonburg | Virginia | 22801 | United States |
| Sentara Hospitals | Norfolk | Virginia | 23507 | United States |
| Southwest VA Regional Cancer Center | Norton | Virginia | 24273 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | United States |
| Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | 23454 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| Saint Francis Hospital | Federal Way | Washington | 98003 | United States |
| Virginia Mason CCOP | Seattle | Washington | 98101 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Cancer Care Northwest-North Spokane | Spokane | Washington | 99218 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| Compass Oncology Vancouver | Vancouver | Washington | 98684 | United States |
| Legacy Salmon Creek Hospital | Vancouver | Washington | 98686 | United States |
| Appleton Medical Center | Appleton | Wisconsin | 54911 | United States |
| Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | United States |
| Bellin Memorial Hospital | Green Bay | Wisconsin | 54301 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Saint Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311-6519 | United States |
| UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | 53038 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Vince Lombardi Cancer Clinic-Marinette | Marinette | Wisconsin | 54143 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin | 53211 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Wheaton Franciscan Cancer Care - All Saints | Racine | Wisconsin | 53405 | United States |
| Door County Cancer Center | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| The Alyce and Elmore Kraemer Cancer Care Center | West Bend | Wisconsin | 53095 | United States |
| Riverview Hospital | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BCCA-Cancer Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BCCA-Vancouver Island Cancer Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| QEII Health Sciences Centre/Capital District Health Authority | Halifax | Nova Scotia | B3H 1V8 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Ottawa Health Research Institute-General Division | Ottawa | Ontario | K1H 1C4 | Canada |
| Irving Greenberg Family Cancer Centre | Ottawa | Ontario | K2H 8P4 | Canada |
| Thunder Bay Regional Health Science Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Québec | Quebec | G1R 2J6 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide). |
| Eligible |
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| Eligible, started protocol treatment, has adverse event data |
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| Eligible with radiation treatment data |
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| Eligible and consented to quality of life component |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Eligible participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dose-Escalated Radiation Therapy Alone | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. |
| BG001 | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of LHRH agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Zubrod Performance Status | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death | Count of Participants | Participants |
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| Number of risk factors | Risk factors are defined as Gleason Score 7; 10< baseline PSA ≤20; T-Stage T2b-T2c. | Count of Participants | Participants |
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| Comorbidity Status [Adult Comorbidity Evaluation 27 (ACE-27) ] | The Adult Comorbidity Evaluation 27 (ACE-27) is a chart-based comorbidity index providing a score (0-3) based on the number and severity of medical comorbidities for patients with cancer: 0=none, 1=mild, 2=moderate, 3=severe. | Count of Participants | Participants |
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| Radiation Therapy Modality | Count of Participants | Participants |
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| Prostate-Specific Antigen (PSA) ng/mL | Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred. | Count of Participants | Participants |
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| Gleason Score | Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive. | Count of Participants | Participants |
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| T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. | Count of Participants | Participants |
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| N-Stage | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) 6th ed. refers to the number and/or extent of spread of lymph nodes that contain cancer. N0 means lymph nodes aren't involved. A higher number means the cancer is in more lymph nodes, farther away from the original tumor. NX means the lymph nodes cannot be assessed. | Count of Participants | Participants |
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| M-Stage | Metastasis stage per the American Joint Committee on Cancer (AJCC) 6th ed. refers to the spread of the cancer to organs and tissues in other parts of the body. M0 = No distant metastasis; M1 = Distant metastasis; MX = Distant metastasis cannot be assessed. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Alive (Overall Survival) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants With Biochemical Failure | Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants With Local Recurrence | Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence [this date is used] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants With Regional Recurrence | Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure. | Regional recurrence data was not collected and therefore cannot be reported. | Posted | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years. |
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| Secondary | Percentage of Participants With Distant Metastasis | Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality) | Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT) | Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants with radiation treatment data. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Secondary | Number of Participants With Acute Adverse Events | Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy. | Eligible participants who started protocol treatment and have adverse event data | Posted | Count of Participants | Participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. |
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| Secondary | Percentage of Participants With Late Grade 3+ Adverse Events | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants who started protocol treatment and have adverse event data | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here. |
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| Secondary | Percentage of Participants Failed (Freedom From Failure) | Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here. |
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| Secondary | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Eligible participants who consented to quality of life component and have data at baseline and time point. | Posted | Mean | Standard Deviation | score on a scale | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Eligible participants who consented to quality of life component and have data at baseline and time point. | Posted | Mean | Standard Deviation | score on a scale | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Eligible participants who consented to quality of life component and have data at baseline and time point. | Posted | Mean | Standard Deviation | score on a scale | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score | The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement. | Eligible participants who consented to quality of life component and have data at baseline and time point. | Posted | Mean | Standard Deviation | score on a scale | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Domain Score | The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year. | Participants who consented to QOL component and have data at baseline and timepoint. | Posted | Mean | Standard Deviation | score on a scale | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Quality Adjusted Life Years (QALYs) | The protocol states that this outcome measure will be analyzed only if the primary endpoint hypothesis is substantiated, which it was not. Therefore no patients were analyzed. | Posted | Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT. |
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| Secondary | Correlation Between PROMIS Fatigue Score Change and Plasma Cytokine Change | The protocol did not provide sufficient detail to meet current National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified analysis, therefore no assays were performed, and no data were collected for this outcome measure (cytokine levels). Specimen use will require future federal approval and funding separate from this trial. | Posted | From date of randomization to 3 weeks from start of RT. |
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| Other Pre-specified | Percentage of Participants Alive (Overall Survival) by Ethnicity | NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants. Data stratified by ethnicity. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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| Other Pre-specified | Percentage of Participants Alive (Overall Survival) by Race | NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported. | Eligible participants. Data stratified by race. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here. |
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End of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment and had adverse event data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-Escalated Radiation Therapy Alone | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. | 119 | 750 | 20 | 733 | 597 | 733 |
| EG001 | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of LHRH agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide). | 100 | 742 | 33 | 725 | 647 | 725 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cardiac disorder | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cardiac valve disease | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cardiopulmonary arrest | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Myocardial ischemia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Restrictive cardiomyopathy | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Anal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rectal ulcer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE (3.0) | Non-systematic Assessment |
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| Sudden death | General disorders and administration site conditions | CTCAE (3.0) | Non-systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Abdominal infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Bladder infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neck NOS infection [other] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sepsis [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Soft tissue infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Soft tissue infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection [with normal or Grade 1-2 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary tract infection [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac troponin I increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Serum cholesterol increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [other] | General disorders and administration site conditions | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Jun 7, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2015 | Jun 7, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D005485 | Flutamide |
| D000726 | Androgen Antagonists |
| D007987 | Gonadotropin-Releasing Hormone |
| D013812 | Therapeutics |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| D002064 | Buserelin |
| D017329 | Triptorelin Pamoate |
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| 60 - 69 years |
|
| ≥ 70 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| Missing |
|
| Two or three |
|
| ACE-27 ≥ grade 2 |
|
| EBRT + LDR brachytherapy boost |
|
| EBRT + HDR brachytherapy boost |
|
| 10-20 |
|
| 7 |
|
| T2 |
|
| N1 |
|
| NX |
|
| M1 |
|
| MX |
|
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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|
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of LHRH agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide). |
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| Participants |
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