Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
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, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.
|Prostate Cancer||Drug: bicalutamide Radiation: Radiation therapy Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||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|
- Overall Survival [ Time Frame: From date of randomization to date of death. ]
- Disease Specific Survival [ Time Frame: From date of randomization to date of death certified as prostatic cancer or death with know rising PSA or death with known progressive metastatic disease or death due to complication of treatment ]
- Time to Distant Failure [ Time Frame: From the date of randomization to the date of first documented metastatic disease. ]
- Non-disease Specific Survival [ Time Frame: From the date of randomization to the date of any death that is not disease specific. ]
- Freedom from Progression [ Time Frame: From the date of randomization to the date of first occurrence of PSA failure, clinical failure or death from any cause. ]
|Study Start Date:||February 1998|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Radiation therapy + bicalutamide
One (150 mg) tablet of Casodex by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
Other Name: CasodexRadiation: Radiation 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.
Placebo Comparator: Placebo
Radiation therapy + Placebo
Radiation: Radiation 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.Drug: Placebo
Patients receive one placebo tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
- Compare overall survival following radiotherapy with or without bicalutamide in patients with an elevated prostate-specific antigen (PSA) and no evidence of metastatic disease following radical prostatectomy for pathologic T3 N0 prostate cancer.
- Compare each regimen with respect to time to second PSA-based progression, time to distant failure, disease-specific survival, and non-disease-specific survival in this patient population.
- Compare each regimen with respect to time to third PSA failure (or PSA progression on hormone therapy for second PSA failure) as a potential predictor for impending cancer death in these patients.
- Compare each regimen with respect to 5-year and 10-year freedom from progression rates.
- Compare each regimen with respect to unintended adverse effects on treatment.
- Allow for subsequent analysis of emerging molecular pathologic predictors of outcome with the prospective collection of paraffin blocks from the radical prostatectomy specimen.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified by neoadjuvant hormone therapy, surgical (inked) margin status, PSA nadir after surgery, PSA level at entry, and participating center.
All patients undergo radiotherapy to the original prostate volume, tumor resection bed, and proximal membranous urethra over 7.2 weeks. Beginning immediately upon or just prior to the initiation of radiotherapy, patients are randomized to receive either bicalutamide or placebo daily for 2 years.
Recommended treatment for patients with increasing PSA and bone metastases consists of maximal androgen blockage with a combination of orchiectomy or LHRH analogues plus bicalutamide or flutamide.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 810 patients will be accrued for this study within approximately 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002874
Show 240 Study Locations
|Study Chair:||William U. Shipley, MD, FACR||Massachusetts General Hospital|
|Study Chair:||H. B. Grossman, MD||M.D. Anderson Cancer Center|