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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000288823 | |||
| NCI-2009-01091 | 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 sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBRT + Brachytherapy | Experimental | External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110) |
|
| Brachytherapy Only | Active Comparator | Transperineal interstitial permanent brachytherapy (125/145) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy (100/110) | Radiation | 100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-Year Freedom From Progression Rate | A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. | From randomization to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Failure Rate (Protocol Definition) | Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy | Analysis occurs after all patients have been potentially followed for 5 years. | |
| 5-Year Freedom From Progression Rate by Ethnicity |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Intermediate-risk disease, as defined by 1 of the following:
No evidence of distant metastases
Prostate volume ≤ 60 cc by transrectal ultrasonography
American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Prior neoadjuvant hormonal therapy allowed provided the following are true:
No concurrent hormonal therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Bradley R. Prestidge, MD | Bon Secours Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | United States | ||
| Auburn Radiation Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37315297 | Derived | Michalski JM, Winter KA, Prestidge BR, Sanda MG, Amin M, Bice WS, Gay HA, Ibbott GS, Crook JM, Catton CN, Raben A, Bosch W, Beyer DC, Frank SJ, Papagikos MA, Rosenthal SA, Barthold HJ, Roach M 3rd, Moughan J, Sandler HM. Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial. J Clin Oncol. 2023 Aug 20;41(24):4035-4044. doi: 10.1200/JCO.22.01856. Epub 2023 Jun 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | EBRT + Brachytherapy | External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110) |
| FG001 | Brachytherapy Only | Transperineal interstitial permanent brachytherapy (125/145) |
| 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 17, 2014 |
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| Brachytherapy (125/145) | Radiation | 125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry. |
|
| External Beam Radiation Therapy | Radiation | Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted. |
|
|
| From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| Biochemical Failure (Phoenix Definition) | Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years. |
| Prostate Cancer Death | Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| Local Failure | Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| Distant Metastases | Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported. | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| Overall Survival | Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported. | From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] | Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity 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 based. | Zero to 180 days from the start of radiation |
| Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] | Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity 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 toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported. | From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years. |
| Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months | The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months. | Baseline and 4 months after start of radiation |
| Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months | The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months. | Baseline and 24 months after start of radiation |
| Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months | The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint. | Baseline and 4 months after start of radiation |
| Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months | The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint. | Baseline and 24 months after start of radiation |
| Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months | The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint. | Baseline and 4 months after start of radiation |
| Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months | The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint. | Baseline and 24 months after start of radiation |
NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. |
| From randomization to 5 years |
| 5-Year Freedom From Progression Rate by Race | NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. | From randomization to 5 years |
| Auburn |
| California |
| 95603 |
| United States |
| Alta Bates Summit Comprehensive Cancer Center | Berkeley | California | 94704 | United States |
| Peninsula Medical Center | Burlingame | California | 94010 | United States |
| Radiation Oncology Centers - Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States |
| Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California | 94546 | United States |
| Valley Medical Oncology | Fremont | California | 94538 | United States |
| California Cancer Center - Woodward Park Office | Fresno | California | 93720 | United States |
| Kaiser Permanente Medical Center - Hayward | Hayward | California | 94545 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| El Camino Hospital Cancer Center | Mountain View | California | 94040 | United States |
| Sutter Health - Western Division Cancer Research Group | Novato | California | 94945 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Breast Surgeons, Incorporated | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Larry G Strieff MD Medical Corporation | Oakland | California | 94609 | United States |
| Tom K Lee, Incorporated | Oakland | California | 94609 | United States |
| Kaiser Permanente - Division of Research - Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente Medical Center - Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente Medical Center - Rancho Cordova | Rancho Cordova | California | 95670 | United States |
| Kaiser Permanente Medical Center - Redwood City | Redwood City | California | 94063 | United States |
| Kaiser Permanente Medical Center - Richmond | Richmond | California | 94801 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | United States |
| Kaiser Permanente Medical Center - Roseville | Roseville | California | 95661 | United States |
| Radiation Oncology Center - Roseville | Roseville | California | 95661 | United States |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | 95815 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| South Sacramento Cancer Center | Sacramento | California | 95823 | United States |
| South Sacramento Kaiser-Permanente Medical Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente Medical Center - Sacramento | Sacramento | California | 95825 | United States |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco | California | 94115 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| California Pacific Medical Center - California Campus | San Francisco | California | 94118 | United States |
| Kaiser Permanente Medical Center - Santa Teresa | San Jose | California | 95119 | United States |
| Kaiser Foundation Hospital - San Rafael | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara | California | 95051 | United States |
| Santa Clara | California | 95051 | United States |
| Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa | California | 95403 | United States |
| Kaiser Permanente Medical Center - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente Medical Facility - Stockton | Stockton | California | 95210 | United States |
| Solano Radiation Oncology Center | Vacaville | California | 95687 | United States |
| Sutter Solano Medical Center | Vallejo | California | 94589 | United States |
| Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Hospital of Saint Raphael | New Haven | Connecticut | 06511 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| St. Agnes Hospital Cancer Center | Baltimore | Maryland | 21229 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| Shields Radiation Oncology Center - Mansfield | Mansfield | Massachusetts | 02048 | United States |
| South Suburban Oncology Center | Quincy | Massachusetts | 02169 | United States |
| Winchester Hospital Radiation Oncology Center | Winchester | Massachusetts | 01890 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| St. Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | City of Saint Peters | Missouri | 63376 | United States |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| St. Joseph Medical Center | Kansas City | Missouri | 64114 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Parvin Radiation Oncology | Kansas City | Missouri | 64116 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Liberty Hospital | Liberty | Missouri | 64068 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | 64507 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Barnes-Jewish West County Hospital | St Louis | Missouri | 63141 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Renown Institute for Cancer at Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire | 03431 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | 08053 | United States |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees Township | New Jersey | 08043 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Sands Cancer Center | Canandiaqua | New York | 14424 | United States |
| Beth Israel Medical Center - Petrie Division | New York | New York | 10003-3803 | United States |
| Highland Hospital of Rochester | Rochester | New York | 14620 | United States |
| University Radiation Oncology at Parkridge Hospital | Rochester | New York | 14626 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Coleman Radiation Oncology Center at Carter General Hospital | Morehead City | North Carolina | 28557 | United States |
| CarolinaEast Cancer Care | New Bern | North Carolina | 28560 | United States |
| South Atlantic Radiation Oncology, LLC | Supply | North Carolina | 28462 | United States |
| Coastal Carolina Radiation Oncology Center | Wilmington | North Carolina | 28401 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Radiation Oncology Center | Alliance | Ohio | 44601 | United States |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Community Cancer Center | Elyria | Ohio | 44035 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| York Cancer Center at Apple Hill Medical Center | York | Pennsylvania | 17405 | United States |
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Norris Cotton Cancer Center - North | Saint Johnsbury | Vermont | 05819 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | 98405-3004 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin | 53211 | United States |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | 53405 | United States |
| West Allis Memorial Hospital | West Allis | Wisconsin | 53227 | United States |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Eligible patients |
|
| Has acute adverse event data | Eligible patients who started study treatment |
|
| Has late adverse event data | Eligible patients who started study treatment and are alive 181 days after start of radiation |
|
| COMPLETED | Subjects contributing any data to analysis are considered to have completed the study. |
|
| NOT COMPLETED |
|
|
Eligible Patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EBRT + Brachytherapy | External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110) |
| BG001 | Brachytherapy Only | Transperineal interstitial permanent brachytherapy (125/145) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
| |||||||||||||||||
| Zubrod Performance Status | Measure Description: 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 |
| |||||||||||||||||
| Combined Gleason Score (GS) | 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 |
| |||||||||||||||||
| Gleason Score & PSA | 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 |
| |||||||||||||||||
| Neoadjuvant Hormone Therapy | 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 | 5-Year Freedom From Progression Rate | A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to 5 years |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Failure Rate (Protocol Definition) | Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biochemical Failure (Phoenix Definition) | Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prostate Cancer Death | Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Local Failure | Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Distant Metastases | Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported. | All Eligible Patients | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] | Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity 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 based. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | Zero to 180 days from the start of radiation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall] | Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity 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 toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported. | Eligible patients who started study treatment and had follow-up data > 180 days from the start of treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months | The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months. | Eligible patients with baseline and 4-month EPIC data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 months after start of radiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months | The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months. | Eligible patients with baseline and 24-month EPIC data | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months after start of radiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months | The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint. | Eligible patients who had a total AUA-SI score at baseline and 4 months | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 months after start of radiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months | The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint. | Eligible patients who had a total AUA-SI score at baseline and 24 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months after start of radiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months | The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint. | Questionnaires were not completed by all eligible participants. 218 and 227 EBRT + Brachytherapy participants had VAS and index score data, respectively, at baseline and 4 months; 237 and 248 Brachytherapy Only participants had VAS and index score data, respectively, at baseline and 4 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 months after start of radiation |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months | The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint. | Questionnaires were not completed by all eligible participants. 210 and 212 EBRT + Brachytherapy participants had VAS and index score data, respectively, at baseline and 24 months; 212 and 226 Brachytherapy Only participants had VAS and index score data, respectively, at baseline and 24 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 months after start of radiation |
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| Other Pre-specified | Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy | The pilot portion of the trial determined that the data required for this analysis was not able to be obtained, and therefore, there are no results for this outcome measure. | Posted | Count of Participants | Participants | Analysis occurs after all patients have been potentially followed for 5 years. |
|
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| Other Pre-specified | 5-Year Freedom From Progression Rate by Ethnicity | NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. | All Eligible Patients. Data stratified by ethnicity. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to 5 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 5-Year Freedom From Progression Rate by Race | NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method. | All Eligible Patients. Data stratified by race. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to 5 years |
|
|
From randomization to last follow-up. Maximum follow-up at time of analysis was 13.9 years.
Eligible patients who started study treatment are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
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 | EBRT + Brachytherapy | 45 Gy EBRT to the prostate and seminal vesicles (1.8 Gy daily over 5 weeks) followed within 2-4 weeks by transperineal interstitial permanent brachytherapy as 100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds. | 46 | 282 | 52 | 282 | 220 | 282 |
| EG001 | Brachytherapy Only | Transperineal interstitial permanent brachytherapy as 125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry. | 55 | 288 | 41 | 288 | 208 | 288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Circulatory or cardiac-Other | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Small/Large Intestine: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Proctitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other : NOS | General disorders and administration site conditions | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Headache NOS | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder/Other GU : NOS | Renal and urinary disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Impotence | Reproductive system and breast disorders | CTC (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other GI : NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Late RT Toxicity: Small/Large Intestine: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Other : NOS | General disorders and administration site conditions | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Bladder/Other GU : NOS | Renal and urinary disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTC (2.0) | 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 |
| Aug 22, 2019 |
| Prot_SAP_ICF_000.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 |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| 70-79 |
|
| ≥ 80 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 10-20 ng/ml |
|
| 1 |
|
| 7 |
|
| GS 7 and PSA < 10 |
|
| T2 |
|
| No |
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|---|---|
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Transperineal interstitial permanent brachytherapy (125/145) |
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|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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