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CompletedNCT00002874Updated Jun 15, 2022Results posted

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

A Phase 3 interventional study of bicalutamide and radiation therapy in Prostate Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 240 sites in 2 countries. Open to male participants. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
840
Allocation
Randomized
Sex
Male
01

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • recurrent prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 840 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Conditions for Patient Eligibility:

  • The patient on entry will have no clinical evidence of disease by physical exam or by imaging studies. A positive ProstaScint scan alone without a confirmatory biopsy must not be used to exclude a patient. Eligible patients will be those who have undergone a radical prostatectomy (either retropubic or perineal) and pelvic lymphadenectomy (either open or laparoscopic) for carcinoma of the prostate, pathologic stage T3N0, or pT2 pN0 with positive inked resection margin, at least 12 weeks prior to study entry.
  • Pathological T2 patients without positive margins, who are also pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer, are eligible.
  • At entry, the PSA must be between 0.2 and 4.0ng/ml, inclusive.
  • A post-prostatectomy radioisotopic bone scan which was done within 16 weeks prior to entry must reveal no evidence of metastatic disease.
  • Patient must be evaluated by both the radiation oncologist and the urologist prior to entry and judged to be a suitable candidate for radiation and hormonal therapy.
  • Patient must have Karnofsky performance status >= 80.
  • Patients must have a life expectancy in excess of 10 years.
  • Patients must have, within 6 weeks prior to entry, a hemoglobin (Hgb) of >=10 gm, a white blood cell (WBC) count of >= 4000 cells/ml3, a platelet count of >= 100,000 cells/ml3, a serum bilirubin \<= the institutional upper limit of normal, a serum serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) of \<= 2.5 times the institutional upper limit of normal, and a serum creatinine of \<= 2.0 times the institutional upper limit of normal.
  • A post-prostatectomy pelvic computerized tomography (CT) scan, within 16 weeks prior to randomization, must reveal no evidence of metastatic disease.
  • Patients must sign a study-specific informed consent form.
  • Patients with prior invasive cancers are eligible if disease free for at least 5 years; prior or concurrent basal or squamous cell skin cancer is eligible.

Conditions for Patient Ineligibility:

  • Pathologic stage T2 (without positive inked resection margin) or less except as stated in Section 3.1.1.1.
  • Pathologic lymph node stage of pN1 or greater.
  • An entry serum PSA of > 4.0ng/ml.
  • Patients with persistant urinary extravasation after prostatectomy.
  • Patients who have been previously treated with any hormonal therapy after prostatectomy.
  • Patients who have previously been treated with radiation therapy or biologic therapy for prostate cancer.
  • Karnofsky performance status \< 80.
  • Treatment start > 4 weeks after randomization.
  • Prior chemotherapy for any reason.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
840 participants (actual)

Study arms

  • Experimental
    Bicalutamide

    Radiation therapy + bicalutamide

    Drug: bicalutamide · Radiation: radiation therapy

  • Placebo comparator
    Placebo

    Radiation therapy + placebo

    Radiation: radiation therapy · Drug: placebo

Interventions

  • Drugbicalutamide

    One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

    Also known as: Casodex

  • Radiationradiation therapy

    64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.

  • Drugplacebo

    One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

06

What researchers measure

Primary outcomes

  1. Overall Survival (12-year Rates Reported)

    Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

    Time frame: From date of randomization to 12 years.

Secondary outcomes

  1. Non-Prostate Cancer Death (12-year Rates Reported)

    Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.

    Time frame: From date of randomization to 12 years.

  2. Second PSA Recurrence (12-year Rates Reported)

    Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

    Time frame: From date of randomization to 12 years.

  3. Third PSA Recurrence (12-year Rates Reported)

    Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

    Time frame: From start of salvage hormone therapy to 12 years.

  4. PSA Complete Response at End of Protocol Treatment

    Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA \< 05 ng/ml.

    Time frame: End of protocol treatment, which is planned to last for two years

  5. Distant Failure (12-year Rates Reported)

    Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

    Time frame: From date of randomization to 12 years.

  6. Prostate Cancer Death (12-year Rates Reported)

    Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Prostate cancer death" is a more accurate wording for the protocol endpoint of "disease-specific survival", and matches the protocol definition.

    Time frame: From date of randomization to 12 years.

  7. Progression-free Survival (12-year Rates Reported)

    Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.

    Time frame: From date of randomization to 12 years.

  8. Grade 3+ Toxicity

    Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.

    Time frame: From date of randomization to four years.

07

Results

Posted Aug 18, 2017

Participant flow

Participant flow — Overall Study
MilestoneBicalutamidePlacebo
Started421419
Completed376384
Not completed4535
Withdrew: Withdrawal by subject11
Withdrew: Protocol violation4434

Outcome measures

PrimaryOverall Survival (12-year Rates Reported)

Overall survival rates were estimated by the Kaplan-Meier method, with failure defined as death by any cause. Four-year follow-up was required of all patients, twelve-year rates are reported. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Overall Survival (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Overall Survival (12-year Rates Reported)71.3 (66.5 to 76.0)76.3 (71.9 to 80.8)
Statistical analysis
  • Placebo vs Bicalutamide · Log Rank · p = 0.020 (One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.) · Hazard ratio (hr): 0.77 · 95% CI 0.59 to 0.98Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.
SecondaryNon-Prostate Cancer Death (12-year Rates Reported)

Non-prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as any death that does not fall into the following categories: death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. All other deaths are considered competing risks. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Non-Prostate cancer death" is a more accurate wording for the protocol endpoint of "non-disease-specific survival", and matches the protocol definition.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Non-Prostate Cancer Death (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Non-Prostate Cancer Death (12-year Rates Reported)15.3 (11.8 to 19.3)17.9 (14.0 to 22.1)
Statistical analysis
  • Placebo vs Bicalutamide · Gray's test · p = 0.289 · Cox proportional hazard: 1.10 · 95% CI 0.79 to 1.53One-sided test
SecondarySecond PSA Recurrence (12-year Rates Reported)

Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Second PSA Recurrence (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Second PSA Recurrence (12-year Rates Reported)67.9 (62.7 to 72.5)44.0 (38.8 to 49.1)
Statistical analysis
  • Placebo vs Bicalutamide · Gray's test · p = <0.001 · Hazard ratio (hr): 0.48 · 95% CI 0.40 to 0.58Reference level = placebo arm
SecondaryThird PSA Recurrence (12-year Rates Reported)

Third PSA recurrence rates (i.e. second PSA failure on study) were estimated by the cumulative incidence method, with failure defined as PSA value of 0.5ng/ml or higher or any disease progression after starting salvage hormone therapy. Patients alive without third PSA recurrence at time of analysis were censored. Death without third PSA recurrence was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

Time frame:
From start of salvage hormone therapy to 12 years.
Reported as:
Number · percentage of participants
Third PSA Recurrence (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Third PSA Recurrence (12-year Rates Reported)80.7 (73.2 to 86.3)84.2 (75.0 to 90.3)
Statistical analysis
  • Placebo vs Bicalutamide · Gray's test · p = 0.213 · Hazard ratio (hr): 1.11 · 95% CI 0.85 to 1.46Reference level = placebo arm
SecondaryPSA Complete Response at End of Protocol Treatment

Complete response is defined as a drop in PSA on protocol treatment to less than 0.2 ng/ml. Note that when the study opened many institutions could not detect PSA \< 05 ng/ml.

Time frame:
End of protocol treatment, which is planned to last for two years
Reported as:
Count of participants · Participants
PSA Complete Response at End of Protocol Treatment
ParticipantsPlaceboBicalutamide
PSA Complete Response at End of Protocol Treatment259360
Statistical analysis
  • Placebo vs Bicalutamide · Chi-squared · p = <0.001
SecondaryDistant Failure (12-year Rates Reported)

Distant failure rates were estimated by the cumulative incidence method, with failure defined as the first occurrence of distant failure. Patients alive without distant metastases at time of analysis were censored. Death without distant metastasis was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Distant Failure (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Distant Failure (12-year Rates Reported)23.0 (18.8 to 27.5)14.5 (11.1 to 18.5)
Statistical analysis
  • Placebo vs Bicalutamide · Gray's test · p = 0.002 · Hazard ratio (hr): 0.63 · 95% CI 0.46 to 0.87Reference level = placebo arm
SecondaryProstate Cancer Death (12-year Rates Reported)

Prostate cancer death rates were estimated by the cumulative incidence method, with failure defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), death with known progressive metastatic disease while on salvage hormone therapy, or death with a known rising PSA while on salvage hormone therapy. Patients alive at time of analysis were censored. Any other death was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Prostate cancer death" is a more accurate wording for the protocol endpoint of "disease-specific survival", and matches the protocol definition.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Prostate Cancer Death (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Prostate Cancer Death (12-year Rates Reported)13.4 (10.1 to 17.2)5.8 (3.6 to 8.6)
Statistical analysis
  • Placebo vs Bicalutamide · Gray's test · p = <0.001 · Hazard ratio (hr): 0.49 · 95% CI 0.32 to 0.74Reference level = placebo arm
SecondaryProgression-free Survival (12-year Rates Reported)

Progress-free survival rates were estimated by the Kaplan-Meier method, with failure defined as the first occurrence of PSA failure, local, regional or distant failure, or death from any cause. Patients alive without progression at time of analysis were censored. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death. "Progression-free Survival" is more accurate wording for the protocol endpoint of "Freedom from Progression", and matches the protocol definition.

Time frame:
From date of randomization to 12 years.
Reported as:
Number · percentage of participants
Progression-free Survival (12-year Rates Reported)
percentage of participantsPlaceboBicalutamide
Progression-free Survival (12-year Rates Reported)23.9 (19.4 to 28.4)38.8 (33.7 to 43.9)
Statistical analysis
  • Placebo vs Bicalutamide · Log Rank · p = < 0.001 · Cox proportional hazard: 0.60 · 95% CI 0.50 to 0.71One-side test
SecondaryGrade 3+ Toxicity

Adverse events are graded using the Cooperative Group Common Toxicity Criteria and the Radiation Therapy Oncology Group (RTOG) Radiation Morbidity Scoring. Grade refers to severity, assigning Grades 1 through 5 based on this general guideline: Grade 0 None, Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related toxicity. Toxicities reported to have occurred within 90 days from the start of radiotherapy are reported as "Acute Radiotherapy", all later toxicities are reported as "Hormone therapy and late radiotherapy toxicity". The highest grade toxicity event per subject is counted within each of these time periods. Four-year follow-up was required of all patients; patients are followed until death.

Time frame:
From date of randomization to four years.
Reported as:
Number · participants
Grade 3+ Toxicity
participantsPlaceboBicalutamide
Acute radiotherapy toxicity178
Hormone therapy and late radiotherapy toxicity73100
Statistical analysis
  • Placebo vs Bicalutamide · Chi-squared · p = 0.060
  • Placebo vs Bicalutamide · Chi-squared · p = 0.029

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—84/382 (22%)346/382 (90.6%)
Bicalutamide—97/374 (25.9%)374/374 (100%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventPlaceboBicalutamide
Bladder/GU: NOSRenal and urinary disorders28/38230/374
Impotence: NOSReproductive system and breast disorders28/38216/374
Cardiac: NOSCardiac disorders18/3826/374
Other: NOSGeneral disorders16/38216/374
Acute RT Toxicity: Bladder: NOSRenal and urinary disorders4/38211/374
Bowel/GI: NOSGastrointestinal disorders10/3828/374
Neurologic: NOSNervous system disorders8/3825/374
Pain: NOSGeneral disorders2/3826/374
Hematologic: NOSBlood and lymphatic system disorders5/3825/374
Acute RT Toxicity: Bowel: NOSGastrointestinal disorders1/3823/374
Most frequent other events
Showing 10 of 18
Most frequent other events
EventPlaceboBicalutamide
Gynecomastia: NOSReproductive system and breast disorders266/38242/374
Acute RT Toxicity: Bowel: NOSGastrointestinal disorders232/382235/374
Bladder/GU: NOSRenal and urinary disorders232/382222/374
Bowel/GI: NOSGastrointestinal disorders192/382168/374
Acute RT Toxicity: Bladder: NOSRenal and urinary disorders188/382165/374
Other: NOSGeneral disorders129/382100/374
Acute RT Toxicity: Skin: NOSInjury, poisoning and procedural complications87/38288/374
Hot flashes: NOSVascular disorders83/38267/374
Acute RT Toxicity: Other: NOSGeneral disorders68/38250/374
Pain: NOSGeneral disorders54/38265/374

Baseline characteristics

Eligible patients who have not withdrawn

Age, Continuous
Age, Continuous(years)BicalutamidePlaceboTotal
Median65 (45 to 81)65 (40 to 83)65 (40 to 83)
Sex: Female, Male
Sex: Female, Male(Participants)BicalutamidePlaceboTotal
Female000
Male376384760
08

Study locations

240 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
  • Comprehensive Cancer Institute of Huntsville
    Huntsville, Alabama 35801, United States
  • Huntsville Hospital System
    Huntsville, Alabama 35807, United States
  • MBCCOP - Gulf Coast
    Mobile, Alabama 36688, United States
  • Alabama Oncology, LLC
    Montgomery, Alabama 36106-3657, United States
  • Radiation Oncology Associates of West Alabama
    Tuscaloosa, Alabama 35401, United States
  • Foundation for Cancer Research and Education
    Phoenix, Arizona 85013, United States
  • Mount Diablo Medical Center
    Concord, California 94524-4110, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • Saint Agnes Cancer Center
    Fresno, California 93720, United States
  • California Cancer Center
    Fresno, California 93729-5100, United States
  • Sutter Health West Cancer Research Group
    Greenbrae, California 94904, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Veterans Affairs Medical Center - Long Beach
    Long Beach, California 90822, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California 90025-1781, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90033-0804, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California 94609-3305, United States
  • Huntington Cancer Center
    Pasadena, California 91105, United States
  • Cancer Care Center
    Pomona, California 91767, United States
  • Radiation Oncology Center - Sacramento
    Sacramento, California 95816, United States
  • Radiation Medical Group, Inc.
    San Diego, California 92101, United States
  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California 94143-0128, United States
  • O'Connor Hospital
    San Jose, California 95128, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California 95403, United States
  • David Grant Medical Center
    Travis Air Force Base, California 94535, United States
  • Memorial Hospital Cancer Center
    Colorado Springs, Colorado 80909, United States
  • University of Colorado Cancer Center
    Denver, Colorado 80010, United States
  • Saint Mary's Hospital and Medical Center
    Grand Junction, Colorado 81502-1628, United States
  • Hospital of St. Raphael
    New Haven, Connecticut 06511, United States
  • CCOP - Christiana Care Health Services
    Wilmington, Delaware 19899, United States
  • University of Florida Health Science Center
    Gainesville, Florida 32610-0385, United States
  • Florida Radiation Oncology Group
    Jacksonville, Florida 32207, United States
  • Health First Holmes Regional Medical Center
    Melbourne, Florida 32901-3276, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Veterans Affairs Medical Center - Miami
    Miami, Florida 33125, United States
  • Sylvester Cancer Center, University of Miami
    Miami, Florida 33136, United States
  • Baptist Hospital of Miami
    Miami, Florida 33256-2110, United States
  • MD Anderson Cancer Center Orlando
    Orlando, Florida 32806, United States
  • Bay Medical Center
    Panama City, Florida 32401, United States
  • Gulf Coast Cancer Treatment Center
    Panama City, Florida 32405-4587, United States
  • Sarasota Radiation and Medical Oncology Center
    Sarasota, Florida 34233, United States
  • Tallahassee Memorial Healthcare
    Tallahassee, Florida 32308, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • Emory University Hospital - Atlanta
    Atlanta, Georgia 30322, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • Medical Center/John B. Amos Community Cancer Center
    Columbus, Georgia 31901, United States
  • Regional Radiation Oncology Center at Rome
    Rome, Georgia 30165, United States
  • MBCCOP - Hawaii
    Honolulu, Hawaii 96813, United States
  • Northwest Community Hospital
    Arlington Heights, Illinois 60005, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • CCOP - Central Illinois
    Decatur, Illinois 62526, United States
  • Ingalls Memorial Hospital
    Harvey, Illinois 60426, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Lutheran General Cancer Care Center
    Park Ridge, Illinois 60068, United States
  • Methodist Medical Center of Illinois
    Peoria, Illinois 61636, United States
  • St. John's Medical Center
    Anderson, Indiana 46016, United States
  • Bloomington Hospital
    Bloomington, Indiana 47402, United States
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    Indianapolis, Indiana 46202, United States
  • Clarian Health Partners Inc.
    Indianapolis, Indiana 46206-1367, United States
  • Regional Cancer Center
    Indianapolis, Indiana 46219, United States
  • Ball Memorial Hospital
    Muncie, Indiana 47303-3499, United States
  • CCOP - Northern Indiana CR Consortium
    South Bend, Indiana 46601, United States
  • Wendt Regional Cancer Center of Finley Hospital
    Dubuque, Iowa 52001, United States
  • Central Baptist Hospital
    Lexington, Kentucky 40503, United States
  • Cancer Center at Lexington Clinic
    Lexington, Kentucky 40504, United States
  • Albert B. Chandler Medical Center, University of Kentucky
    Lexington, Kentucky 40536-0084, United States
  • James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
  • Louisville Radiation Oncology
    Louisville, Kentucky 40215, United States
  • Merle M. Mahr Cancer Center
    Madisonville, Kentucky 42431, United States
  • Mary Bird Perkins Cancer Center
    Baton Rouge, Louisiana 70809, United States
  • Tulane University School of Medicine
    New Orleans, Louisiana 70112-2699, United States
  • MBCCOP - LSU Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • CCOP - Ochsner
    New Orleans, Louisiana 70121, United States
  • Maine Medical Center
    Portland, Maine 04102, United States
  • Anne Arundel Oncology Center
    Annapolis, Maryland 21401, United States
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
    Baltimore, Maryland 21201, United States
  • Greater Baltimore Medical Center and Cancer Center
    Baltimore, Maryland 21204, United States
  • Harbor Hospital Center
    Baltimore, Maryland 21215-1290, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
  • Peninsula Regional Medical Center
    Salisbury, Maryland 21801, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Cape Cod Hospital
    Hyannis, Massachusetts 02601, United States
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Jamaica Plain, Massachusetts 02130, United States
  • CCOP - Ann Arbor Regional
    Ann Arbor, Michigan 48106, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109-0752, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Hurley Medical Center
    Flint, Michigan 48503, United States
  • McLaren Regional Cancer Center
    Flint, Michigan 48532-3685, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49007-3731, United States
  • Marquette General Hospital
    Marquette, Michigan 49855, United States
  • MidMichigan Medical Center - Midland
    Midland, Michigan 48670, United States
  • CCOP - Beaumont
    Royal Oak, Michigan 48073-6769, United States
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • William Beaumont Hospital - Troy
    Troy, Michigan 48098, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • Ellis Fischel Cancer Center - Columbia
    Columbia, Missouri 65203, United States

Showing the first 100 of 240 sites across 2 countries.

09

References and documents

Publications

  • Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529. PubMed 28146658 ↗
  • Modonutti D, Majdalany SE, Corsi N, Li P, Sood A, Dalela D, Jamil ML, Hwang C, Menon M, Rogers CG, Trinh QD, Novara G, Abdollah F. A novel prognostic model predicting overall survival in patients with metastatic castration-resistant prostate cancer receiving standard chemotherapy: A multi-trial cohort analysis. Prostate. 2022 Sep;82(13):1293-1303. doi: 10.1002/pros.24403. Epub 2022 Jul 5. PubMed 35790016 ↗
  • Jackson WC, Tang M, Schipper MJ, Sandler HM, Zumsteg ZS, Efstathiou JA, Shipley WU, Seiferheld W, Lukka HR, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Hall WA, Dess RT, Lovett RD, Balogh AG, Feng FY, Spratt DE. Biochemical Failure Is Not a Surrogate End Point for Overall Survival in Recurrent Prostate Cancer: Analysis of NRG Oncology/RTOG 9601. J Clin Oncol. 2022 Sep 20;40(27):3172-3179. doi: 10.1200/JCO.21.02741. Epub 2022 Jun 23. PubMed 35737923 ↗
  • Feng FY, Huang HC, Spratt DE, Zhao SG, Sandler HM, Simko JP, Davicioni E, Nguyen PL, Pollack A, Efstathiou JA, Dicker AP, Todorovic T, Margrave J, Liu YS, Dabbas B, Thompson DJS, Das R, Dignam JJ, Sweeney C, Attard G, Bahary JP, Lukka HR, Hall WA, Pisansky TM, Shah AB, Pugh SL, Shipley WU, Tran PT. Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):544-552. doi: 10.1001/jamaoncol.2020.7671. Erratum In: JAMA Oncol. 2021 Apr 1;7(4):639. doi: 10.1001/jamaoncol.2021.0552. PubMed 33570548 ↗
  • Dess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109. PubMed 32215583 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00002874
Lead sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), SWOG Cancer Research Network, NRG Oncology
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Feb 1998
Primary completion
Aug 2015
Completion
May 20, 2022
Results posted
Aug 18, 2017
Last update
Jun 15, 2022

Study contacts

William U. Shipley, MD
principal investigator · Massachusetts General Hospital and Harvard Medical School, Boston
Himanshu R Lukka, MD
study chair · Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON
Pierre P Major, MD
study chair · Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON
Niall M Heney, MD
study chair · Massachusetts General Hospital and Harvard Medical School, Boston
David J Grignon, MD
study chair · Indiana University, Indianapolis

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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