A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
Overview
- Phase
- Phase 3
- Intervention
- bicalutamide
- Conditions
- Prostate Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 840
- Locations
- 240
- Primary Endpoint
- Overall Survival (12-year Rates Reported)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Bicalutamide
Radiation therapy + bicalutamide
Intervention: bicalutamide
Bicalutamide
Radiation therapy + bicalutamide
Intervention: radiation therapy
Placebo
Radiation therapy + placebo
Intervention: radiation therapy
Placebo
Radiation therapy + placebo
Intervention: placebo
Outcomes
Primary Outcomes
Overall Survival (12-year Rates Reported)
Time Frame: From date of randomization to 12 years.
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.
Secondary Outcomes
- Second PSA Recurrence (12-year Rates Reported)(From date of randomization to 12 years.)
- Third PSA Recurrence (12-year Rates Reported)(From start of salvage hormone therapy to 12 years.)
- PSA Complete Response at End of Protocol Treatment(End of protocol treatment, which is planned to last for two years)
- Grade 3+ Toxicity(From date of randomization to four years.)
- Non-Prostate Cancer Death (12-year Rates Reported)(From date of randomization to 12 years.)
- Distant Failure (12-year Rates Reported)(From date of randomization to 12 years.)
- Prostate Cancer Death (12-year Rates Reported)(From date of randomization to 12 years.)
- Progression-free Survival (12-year Rates Reported)(From date of randomization to 12 years.)