A Phase 3 interventional study of bicalutamide and flutamide in Prostate Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 518 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs \< 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. After completion of study therapy, patients are followed up periodically.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 1,538 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below:
No evidence of bone (M0) on bone scan within 60 days prior to registration.
Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
Exclusion Criteria:
Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for this trial.
Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
Severe, active co-morbidity, defined as follows:
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions.
Radiation: Dose-Escalated Radiation Therapy
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide).
Drug: bicalutamide · Drug: flutamide · Drug: LHRH agonist (antagonist) therapy · Radiation: Dose-Escalated Radiation Therapy
Administered orally at a dose of one 50 mg tablet per day, beginning within (before, same day as, or after) 10 days of the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.
Administered orally at a dose of 250 mg (two 125-mg capsules) three times a day for a total daily dose of 750 mg, beginning within (before, same day as, or after) 10 days of with the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.
Also known as: anti-androgen therapy
LHRH agonist (antagonist) therapy consists of leuprolide, goserelin, buserelin, triptorelin, or degarelix. The manufacturer's instructions should be followed. The first administration occurs with the start of anti-androgen treatment 8 weeks prior to the start of RT. The total duration of LHRH agonist (antagonist) therapy is 6 months.
Also known as: leuprolide, goserelin, buserelin, triptorelin, degarelix
External beam radiotherapy (EBRT) as 3D Conformal Radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT). Brachytherapy is optional, at the discretion of the treating physician. Patients treated entirely via EBRT receive 79.2 Gy delivered in 1.8 Gy fractions. Patients who receive brachytherapy as a component of their RT receive 45 Gy EBRT in 1.8 Gy fractions. Low-dose brachytherapy boost occurs following the EBRT portion of treatment no more than 4 weeks following its completion.High-dose rate brachytherapy boost is delivered in 2 fractions separated by a minimum time span of 6 hours and the implant(s) may be performed during the EBRT portion of the treatment or within 1 week prior to its initiation or following its completion.
Percentage of Participants Alive (Overall Survival)
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants With Biochemical Failure
Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants With Local Recurrence
Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence \[this date is used\] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants With Regional Recurrence
Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure.
Time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years.
Percentage of Participants With Distant Metastasis
Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality)
Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality)
Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT)
Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Number of Participants With Acute Adverse Events
Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years.
Percentage of Participants With Late Grade 3+ Adverse Events
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here.
Percentage of Participants Failed (Freedom From Failure)
Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates are reported here.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Domain Score
The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Quality Adjusted Life Years (QALYs)
Time frame: Last week of RT (approximately 9 and 17 weeks from start of protocol treatment for Arm 1 and 2, respectively), then 6 months, 1 year and 5 years from end of RT.
Correlation Between PROMIS Fatigue Score Change and Plasma Cytokine Change
Time frame: From date of randomization to 3 weeks from start of RT.
Percentage of Participants Alive (Overall Survival) by Ethnicity
NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
Percentage of Participants Alive (Overall Survival) by Race
NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
Time frame: From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.
| Milestone | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Started | 771 | 767 |
| Eligible | 750 | 742 |
| Eligible, started protocol treatment, has adverse event data | 733 | 725 |
| Eligible with radiation treatment data | 725 | 707 |
| Eligible and consented to quality of life component | 215 | 205 |
| Completed | 750 | 742 |
| Not completed | 21 | 25 |
| Withdrew: Protocol violation | 21 | 25 |
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants Alive (Overall Survival) | 90.0 (87.7 to 92.2) | 91.0 (88.8 to 93.1) |
Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants With Biochemical Failure | 13.9 (11.5 to 16.6) | 7.7 (5.9 to 9.9) |
Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence \[this date is used\] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants With Local Recurrence | 2.6 (1.6 to 4.1) | 0.6 (0.2 to 1.5) |
Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure.
No measurements were reported for this outcome.
Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants With Distant Metastasis | 3.1 (2.0 to 4.6) | 0.6 (0.2 to 1.4) |
Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality) | 0.90 (0.4 to 1.9) | 0 (0 to 0) |
Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality) | 9.1 (7.1 to 11.5) | 9.0 (7.0 to 11.4) |
Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT) | 6.1 (4.5 to 8.1) | 4.2 (2.8 to 5.8) |
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| EBRT | 89.4 (86.9 to 91.9) | 90.3 (87.9 to 92.8) |
| EBRT +LDR Brachytherapy Boost | 100 (100 to 100) | 97.2 (93.3 to 100.0) |
| EBRT +HDR Brachytherapy Boost | 91.7 (76.0 to 100) | 100 (100 to 100) |
Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy.
| Participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Number of Participants With Acute Adverse Events | 152 | 504 |
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants With Late Grade 3+ Adverse Events | 12.8 (10.5 to 15.4) | 15.2 (12.6 to 17.9) |
Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Percentage of Participants Failed (Freedom From Failure) | 14.8 (12.2 to 17.5) | 7.9 (6.0 to 10.1) |
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
| score on a scale | Dose-Escalated Radiation Therapy Alone (Arm 1) | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation (Arm 2) |
|---|---|---|
| End of RT | -12.4 ± 17.0 | -13.8 ± 15.4 |
| Six months post-RT | -0.1 ± 14.9 | -3.6 ± 15.3 |
| One year post-RT | -1.9 ± 15.9 | -1.6 ± 15.3 |
| Five years post-RT | -0.4 ± 14.9 | 0.3 ± 12.3 |
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
| score on a scale | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| End of RT | -9.7 ± 14.7 | -10.5 ± 13.7 |
| Six months post-RT | -2.6 ± 12.8 | -3.8 ± 9.6 |
| One year post-RT | -4.0 ± 12.8 | -5.2 ± 13.4 |
| Five years post-RT | -2.7 ± 13.2 | -2.9 ± 10.7 |
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
| score on a scale | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| End of RT | -1.8 ± 10.2 | -18.4 ± 16.2 |
| Six months post-RT | -0.7 ± 11.9 | -13.7 ± 16.9 |
| One year post-RT | -0.8 ± 14.7 | -7.8 ± 14.4 |
| Five years post-RT | -0.3 ± 15.9 | -2.7 ± 13.9 |
The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.
| score on a scale | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| End of RT | -6.7 ± 18.9 | -22.6 ± 25.8 |
| Six months post-RT | -7.9 ± 23.0 | -19.9 ± 25.3 |
| One year post-RT | -8.5 ± 22.7 | -16.6 ± 23.7 |
| Five years post-RT | -10.0 ± 26.6 | -9.6 ± 27.6 |
The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.
| score on a scale | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| End of RT | 0.80 ± 4.66 | 1.84 ± 5.54 |
| Six months post-RT | 1.09 ± 5.14 | 1.21 ± 5.34 |
| One year post_RT | 0.99 ± 6.00 | 0.86 ± 5.08 |
| Five years post-RT | 0.97 ± 6.71 | 0.80 ± 5.62 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Hispanic or Latino | 94.0 (85.9 to 100.0) | 96.8 (90.6 to 100.0) |
| Not Hispanic or Latino | 89.5 (87.1 to 91.9) | 91.0 (88.8 to 93.3) |
| Unknown for Not Reported | 96.4 (89.6 to 100.0) | 80.7 (63.7 to 97.8) |
NIH-required analysis. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.
| percentage of participants | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| American Indian or Alaska Native | 100 (NA to NA) | 100 (NA to NA) |
| Asian | 100.0 (NA to NA) | 85.7 (59.8 to 100.0) |
| Native Hawaiian or Other Pacific Islander | — | 100 (NA to NA) |
| Black or African American | 90.6 (85.7 to 95.5) | 94.4 (90.6 to 98.2) |
| White | 89.8 (87.1 to 92.4) | 90.3 (87.7 to 92.9) |
| More than one race | 33.3 (0.0 to 86.7) | 100.0 (NA to NA) |
| Unknown or Not Reported | 92.3 (77.8 to 100.0) | 80.2 (59.8 to 100.0) |
Collected over End of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose-Escalated Radiation Therapy Alone | 119/750 (15.9%) | 20/733 (2.7%) | 597/733 (81.4%) |
| Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | 100/742 (13.5%) | 33/725 (4.6%) | 647/725 (89.2%) |
| Event | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Myocardial ischemiaCardiac disorders | 0/733 | 5/725 |
| Urinary retentionRenal and urinary disorders | 4/733 | 2/725 |
| DiarrheaGastrointestinal disorders | 3/733 | 1/725 |
| ProctitisGastrointestinal disorders | 3/733 | 2/725 |
| Urinary frequencyRenal and urinary disorders | 3/733 | 0/725 |
| Rectal hemorrhageGastrointestinal disorders | 1/733 | 2/725 |
| Urinary tract infection [with normal or Grade 1-2 ANC]Infections and infestations | 0/733 | 2/725 |
| ColitisGastrointestinal disorders | 2/733 | 0/725 |
| VomitingGastrointestinal disorders | 2/733 | 1/725 |
| Weight lossInvestigations | 2/733 | 0/725 |
| Event | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation |
|---|---|---|
| Urinary frequencyRenal and urinary disorders | 462/733 | 531/725 |
| Hot flashesVascular disorders | 23/733 | 414/725 |
| Erectile dysfunctionReproductive system and breast disorders | 273/733 | 359/725 |
| FatigueGeneral disorders and administration site conditions | 210/733 | 338/725 |
| Urinary retentionRenal and urinary disorders | 180/733 | 222/725 |
| Urogenital disorderRenal and urinary disorders | 158/733 | 200/725 |
| DiarrheaGastrointestinal disorders | 134/733 | 186/725 |
| Urinary incontinenceRenal and urinary disorders | 125/733 | 136/725 |
| Libido decreasedPsychiatric disorders | 45/733 | 121/725 |
| ProctitisGastrointestinal disorders | 105/733 | 115/725 |
Eligible participants
| Age, Customized(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| Age — ≤ 49 years | 9 | 10 | 19 |
| Age — 50-59 years | 105 | 96 | 201 |
| Age — 60 - 69 years | 361 | 320 | 681 |
| Age — ≥ 70 years | 275 | 316 | 591 |
| Sex: Female, Male(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 750 | 742 | 1492 |
| Ethnicity (NIH/OMB)(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 37 | 78 |
| Not Hispanic or Latino | 681 | 682 | 1363 |
| Unknown or Not Reported | 28 | 23 | 51 |
| Race (NIH/OMB)(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 3 | 6 |
| Asian | 11 | 7 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 158 | 156 | 314 |
| White | 557 | 554 | 1111 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 18 | 18 | 36 |
| Zubrod Performance Status(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| 0 | 642 | 645 | 1287 |
| 1 | 108 | 96 | 204 |
| Missing | 0 | 1 | 1 |
| Number of risk factors(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| One | 504 | 490 | 994 |
| Two or three | 246 | 252 | 498 |
| Comorbidity Status [Adult Comorbidity Evaluation 27 (ACE-27) ](Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| ACE-27 < grade 2 | 246 | 246 | 492 |
| ACE-27 ≥ grade 2 | 504 | 496 | 1000 |
| Radiation Therapy Modality(Participants) | Dose-Escalated Radiation Therapy Alone | Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation | Total |
|---|---|---|---|
| Dose-escalated EBRT | 665 | 656 | 1321 |
| EBRT + LDR brachytherapy boost | 73 | 75 | 148 |
| EBRT + HDR brachytherapy boost | 12 | 11 | 23 |
5 further baseline measures are reported on the registry.
Showing the first 100 of 518 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2009 to primary completion in Oct 2020, 133 months.
Results were first posted in Oct 2022, 2 years after primary completion.
Of 139 non-industry phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 99 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 144. This study's 133 months is above that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bicalutamide · Flutamide · Antagonist
Radiation Therapy Oncology Group →