This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, low-let cobalt-60 gamma ray therapy, low-let photon therapy
Phase phase 3
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 1998
End date December 2016
Trial size 840 participants
Trial identifier NCT00002874, CDR0000065158, RTOG-9601, RTOG-R9601


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Radiation therapy plus Casodex (bicalutamide) 150 mg
bicalutamide Casodex
low-let cobalt-60 gamma ray therapy
low-let photon therapy
(Placebo Comparator)
Radiation therapy plus placebo daily
low-let cobalt-60 gamma ray therapy
low-let photon therapy

Primary Outcomes

Overall Survival
time frame: From date of randomization to date of death.

Secondary Outcomes

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.

Eligibility Criteria

Male participants of any age.

DISEASE CHARACTERISTICS: - Carcinoma of the prostate with pathologic stage T3 N0 or pT2 pN0 with positive inked resection margin at least 12 weeks prior to study entry - Radical prostatectomy (retropubic or perineal) and pelvic lymphadenectomy (open or laparoscopic) required at least 16 weeks prior to entry - No persistent urinary extravasation after surgery - Suitable for radiotherapy and hormonal therapy as determined by the radiation oncologist and urologist - No metastasis by post-prostatectomy radioisotope bone scan within 16 weeks prior to entry - Pathologic stage T2 without positive margins and pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer allowed - PSA 0.2-4.0 ng/mL at study entry - No distant metastases PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Karnofsky 80-100% Life expectancy: - More than 10 years Hematopoietic: - White blood cell count (WBC) at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 - Hematocrit at least 36% - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin normal - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 2.5 times normal Renal: - Creatinine no greater than 2 times normal Other: - No other malignancy within the past 5 years except basal or squamous cell skin cancer or adequately treated invasive cancers PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy for prostate cancer Chemotherapy: - No prior chemotherapy for prostate cancer Endocrine therapy: - No prior adjuvant hormonal therapy - Prior neoadjuvant hormonal therapy allowed Radiotherapy: - No prior radiotherapy for prostate cancer Surgery: - See Disease Characteristics

Additional Information

Description OBJECTIVES: - 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.