Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000382120 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
Not provided
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RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| External Beam Radiotherapy and High Dose brachytherapy boost | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose brachytherapy boost | Radiation | 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment. Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month. Death was treated as a competing risk. | From 9 to 18 months after start of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Acute is defined as occurring within 9 months from the start of study treatment. |
Not provided
Inclusion Criteria:
Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
The patient will be clinically M0.
Zubrod status 0-1.
No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
One of the following combinations of factors:
Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) >10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
Patients must sign a study-specific consent form prior to registration.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| I-Chow J. Hsu, MD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States | ||
| Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20207506 | Result | Hsu IC, Bae K, Shinohara K, Pouliot J, Purdy J, Ibbott G, Speight J, Vigneault E, Ivker R, Sandler H. Phase II trial of combined high-dose-rate brachytherapy and external beam radiotherapy for adenocarcinoma of the prostate: preliminary results of RTOG 0321. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):751-8. doi: 10.1016/j.ijrobp.2009.08.048. Epub 2010 Mar 6. | |
| 18455325 |
Not provided
Not provided
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | External Beam Radiotherapy and High Dose Brachytherapy Boost | High Dose brachytherapy boost: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks. External beam radiotherapy: 45 Gy as 1.8 Gy five days a week for five weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| External beam radiotherapy | Radiation | 45 Gy as 1.8 Gy five days a week for five weeks. |
|
|
| From treatment start to 9 months |
| Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition | The ASTRO criteria for biochemical failure is three consecutive rises in prostate-specific antigen (PSA) level above the nadir after radiation therapy. The PSA nadir is defined as as the lowest PSA value reached immediately before a biochemical failure. The date of failure is midway between the last non-rising PSA and the first rise in PSA. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | From registration to ten years |
| Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition | The Phoenix criteria for biochemical failure is a rise of 2 ng/mL or more above the nadir after radiation therapy. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | From registration to ten years |
| Percentage of Participants Alive at 10 Years | Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rate is estimated by the Kaplan-Meier method. | From registration to 10 years |
| Percentage of Participants With Death Due to Prostate Cancer at 10 Years | The following will be considered as death due to prostate cancer (failure):
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | From registration to ten years |
| Percentage of Participants With Distant Failure at 10 Years | Distant failure required documentation of regional nodal recurrence or distant disease relapse. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | From registration to ten years |
| Percentage of Participants With Local Failure at 10 Years | Local failure is defined as documented local progression as determined by clinical exam. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | From registration to ten years |
| Inglewood |
| California |
| 90301 |
| United States |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center | Boca Raton | Florida | 33486 | United States |
| OSF St. Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | 48073 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | United States |
| Jacob D, Raben A, Sarkar A, Grimm J, Simpson L. Anatomy-based inverse planning simulated annealing optimization in high-dose-rate prostate brachytherapy: significant dosimetric advantage over other optimization techniques. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):820-7. doi: 10.1016/j.ijrobp.2008.02.009. Epub 2008 May 1. |
| 33186617 | Derived | Hsu IC, Rodgers JP, Shinohara K, Purdy J, Michalski J, Roach M 3rd, Vigneault E, Ivker RA, Pryzant RM, Kuettel M, Taussky D, Gustafson GS, Raben A, Sandler HM. Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):700-707. doi: 10.1016/j.ijrobp.2020.11.008. Epub 2020 Nov 10. |
| Eligible and Started Study Treatment |
|
| Eligible, Started Treatment, Has AE Data | Eligible, started study treatment, and has adverse event (AE) data |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible and started protocol treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | External Beam Radiotherapy and High Dose Brachytherapy Boost | High Dose brachytherapy boost: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks. External beam radiotherapy: 45 Gy as 1.8 Gy five days a week for five weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Zubrod Performance Scale | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline Prostate-Specific Antigen (PSA) | 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 |
| ||||||||||||||||||||||
| 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 |
| ||||||||||||||||||||||
| Prior hormone therapy | Did the participant have hormonal therapy within 120 days prior to study registration? | Count of Participants | Participants |
| ||||||||||||||||||||||
| 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. T's may be further divided to provide more detail, such as T3a and T3b. | Count of Participants | Participants |
|
| 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 With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment. Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month. Death was treated as a competing risk. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From 9 to 18 months after start of study treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Acute is defined as occurring within 9 months from the start of study treatment. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From treatment start to 9 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition | The ASTRO criteria for biochemical failure is three consecutive rises in prostate-specific antigen (PSA) level above the nadir after radiation therapy. The PSA nadir is defined as as the lowest PSA value reached immediately before a biochemical failure. The date of failure is midway between the last non-rising PSA and the first rise in PSA. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to ten years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition | The Phoenix criteria for biochemical failure is a rise of 2 ng/mL or more above the nadir after radiation therapy. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to ten years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Alive at 10 Years | Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rate is estimated by the Kaplan-Meier method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to 10 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Death Due to Prostate Cancer at 10 Years | The following will be considered as death due to prostate cancer (failure):
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to ten years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Distant Failure at 10 Years | Distant failure required documentation of regional nodal recurrence or distant disease relapse. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to ten years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Local Failure at 10 Years | Local failure is defined as documented local progression as determined by clinical exam. Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. | Eligible participants who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to ten years |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EBRT and HDR Brachytherapy Boost | External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost. | 49 | 115 | 110 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fanconi syndrome acquired | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthritis NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/soft tissue - Other | Musculoskeletal and connective tissue 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 |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral stricture | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary bladder hemorrhage | 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 hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flushes NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cystitis NOS | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urethral stricture | 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 hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ejaculatory disorder NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flushes NOS | 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 | seiferheldw@nrgoncology.org |
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Measurements |
|---|
|
| 8-10 |
|
|
|
|
|
|
|
|