A Phase 3 interventional study of three-dimensional conformal radiotherapy and intensity modulated radiotherapy in Prostate Cancer, sponsored by Radiation Therapy Oncology Group. Active, not recruiting at 478 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [4-6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.
All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 4-6 or 32 months.
Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.
Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.
Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 2,590 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
Gleason score 6 + T2c-T4 (palpation) + PSA \< 50 ng/ml
-ORGleason score 6 + ≥ 50% (positive) + PSA \< 50 ng/ml;
Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
*No evidence of bone (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration.
Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol.
Radiation: three-dimensional conformal radiotherapy · Radiation: intensity modulated radiotherapy · Radiation: Brachytherapy · Drug: Anti-androgen · Drug: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1.
Radiation: three-dimensional conformal radiotherapy · Radiation: intensity modulated radiotherapy · Radiation: Brachytherapy · Drug: Anti-androgen · Drug: luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
Daily fractions
Daily fractions
Implant
Tablet
Injection
Percentage of Participants Alive (Overall Survival)
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Time frame: From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Percent of Participants Who Died Due to Prostate Cancer
Prostate cancer death rates were estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis.
Time frame: From randomization to death due to prostate cancer or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Percentage of Participants With Distant Metastasis
Distant metastasis rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without distant metastasis at time of analysis.
Time frame: From date of randomization to distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Percentage of Participants With Biochemical Failure
Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without biochemical failure at time of analysis.
Time frame: From date of randomization to the date of biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported.
Number of Participants by Highest Grade Acute Adverse Event Reported
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Acute adverse events are defined as those occurring within 30 days after the completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From protocol treatment start date to 30 days from completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique.
Number of Participants by Highest Grade Late Adverse Event Reported
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Late adverse events are defined as occurring ≥ 30 days after end of RT (approximately weeks 19-22, depending on boost technique). Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From 30 days after completion of radiation therapy (approximately weeks 19-22, depending on boost technique) to highest grade late adverse event. Median follow-up at time of analysis was 6.7 years.
EPIC-26 Urinary Bowel Domain Score Change From Baseline at 6 Months
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
Time frame: Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
EPIC-26 Urinary Irritative/Obstructive Subscore Change From Baseline at 6 Months
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
Time frame: Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
PROMIS Fatigue Score Change From Baseline Line at Last Week of Radiation Treatment
The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.
Time frame: Baseline and last week of radiation treatment, approximately 19-22 weeks, depending on boost technique.
Quality Adjusted Life Years (QALYs)
Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Baseline; the week prior to radiation therapy (RT); the last week of RT; 6 months, 1 year, and 5 years after RT. RT begins about weeks 8-10 after starting protocol therapy and ends about weeks 19-22, depending on boost technique.
| Milestone | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| Started | 1295 | 1295 |
| Eligible | 1228 | 1245 |
| Completed | 1228 | 1245 |
| Not completed | 67 | 50 |
| Withdrew: Protocol violation | 67 | 50 |
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
| Percentage of participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| 5 years | 90.1 (88.2 to 91.7) | 89.8 (88.1 to 91.6) |
| 10 years | 68.2 (64.2 to 72.2) | 68.3 (64.3 to 72.4) |
Prostate cancer death rates were estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis.
| Percentage of participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| 5 years | 0.6 (0.3 to 1.2) | 1.0 (0.6 to 1.8) |
| 10 years | 2.8 (1.7 to 4.5) | 3.1 (1.9 to 4.7) |
Distant metastasis rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without distant metastasis at time of analysis.
| Percentage of participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| 5 years | 2.3 (1.6 to 3.3) | 3.4 (2.4 to 4.5) |
| 10 years | 7.6 (5.6 to 10.1) | 6.4 (4.8 to 8.3) |
Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without biochemical failure at time of analysis.
| Percentage of participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| 5 years | 7.7 (6.3 to 9.4) | 7.4 (6.0 to 9.0) |
| 10 years | 15.1 (12.6 to 17.8) | 12.2 (10.0 to 14.7) |
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Acute adverse events are defined as those occurring within 30 days after the completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
| Participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| None | 392 | 422 |
| Grade 1 | 430 | 374 |
| Grade 2 | 234 | 259 |
| Grade 3 | 149 | 169 |
| Grade 4 | 13 | 10 |
| Grade 5 | 3 | 5 |
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Late adverse events are defined as occurring ≥ 30 days after end of RT (approximately weeks 19-22, depending on boost technique). Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
| Participants | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| None | 190 | 203 |
| Grade 1 | 233 | 232 |
| Grade 2 | 588 | 595 |
| Grade 3 | 185 | 185 |
| Grade 4 | 18 | 20 |
| Grade 5 | 7 | 4 |
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
Results for this outcome have not been posted.
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
Results for this outcome have not been posted.
The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue.
Results for this outcome have not been posted.
Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
No measurements were reported for this outcome.
Collected over From randomization to death or last follow-up. Median follow-up at time of analysis was 6.7 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | 257/1,228 (20.9%) | 114/1,231 (9.3%) | 1,081/1,231 (87.8%) |
| Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | 257/1,245 (20.6%) | 107/1,239 (8.6%) | 1,093/1,239 (88.2%) |
| Event | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| ProctitisGastrointestinal disorders | 9/1231 | 9/1239 |
| Rectal hemorrhageGastrointestinal disorders | 7/1231 | 6/1239 |
| Erectile dysfunctionReproductive system and breast disorders | 7/1231 | 4/1239 |
| AnemiaBlood and lymphatic system disorders | 4/1231 | 7/1239 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/1231 | 6/1239 |
| Myocardial infarctionCardiac disorders | 5/1231 | 3/1239 |
| Urinary tract infectionInfections and infestations | 5/1231 | 4/1239 |
| StrokeNervous system disorders | 5/1231 | 5/1239 |
| Urinary retentionRenal and urinary disorders | 5/1231 | 3/1239 |
| SyncopeNervous system disorders | 3/1231 | 5/1239 |
| Event | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
|---|---|---|
| Urinary frequencyRenal and urinary disorders | 743/1231 | 771/1239 |
| Hot flashesVascular disorders | 732/1231 | 711/1239 |
| FatigueGeneral disorders and administration site conditions | 576/1231 | 622/1239 |
| Erectile dysfunctionReproductive system and breast disorders | 525/1231 | 555/1239 |
| Urinary urgencyRenal and urinary disorders | 487/1231 | 469/1239 |
| DiarrheaGastrointestinal disorders | 263/1231 | 439/1239 |
| Renal and urinary disorders - OtherRenal and urinary disorders | 342/1231 | 362/1239 |
| Urinary retentionRenal and urinary disorders | 269/1231 | 270/1239 |
| Urinary incontinenceRenal and urinary disorders | 228/1231 | 239/1239 |
| ConstipationGastrointestinal disorders | 189/1231 | 158/1239 |
Eligible randomized participants
| Age, Continuous(years) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| Median | 69 (43 to 89) | 69 (44 to 87) | 69 (43 to 89) |
| Sex: Female, Male(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1228 | 1245 | 2473 |
| Race (NIH/OMB)(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 8 | 4 | 12 |
| Asian | 30 | 33 | 63 |
| Native Hawaiian or Other Pacific Islander | 4 | 3 | 7 |
| Black or African American | 225 | 230 | 455 |
| White | 915 | 940 | 1855 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 45 | 35 | 80 |
| Ethnicity (NIH/OMB)(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| Hispanic or Latino | 53 | 49 | 102 |
| Not Hispanic or Latino | 1146 | 1163 | 2309 |
| Unknown or Not Reported | 29 | 33 | 62 |
| Risk group (per stratification)(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| Gleason 7-10+T1c-T2b+PSA<50 | 1200 | 1214 | 2414 |
| Gleason 6+T2c-T4+PSA<50 | 18 | 15 | 33 |
| Gleason 6+T1c-T2b+PSA>20 | 10 | 16 | 26 |
| Type of radiation boost (per stratification)(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| intensity modulated radiotherapy (IMRT) | 971 | 980 | 1951 |
| Brachytherapy (low or high dose rate) | 257 | 265 | 522 |
| Duration of androgen deprivation therapy (ADT) (per stratification)(Participants) | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Total |
|---|---|---|---|
| 4 months (short term) | 121 | 123 | 244 |
| 6 months (short term) | 720 | 756 | 1476 |
| 32 months (long term) | 387 | 366 | 753 |
Showing the first 100 of 478 sites across 6 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Data sharing details ↗ · grants.nih.gov
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Studies of the drugs tested here: Antiandrogens · Gonadotropin-Releasing Hormone
Radiation Therapy Oncology Group →