Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentClosedAny ageNCI, OtherRTOG-9601
CDR0000065158, RTOG-R9601, NCT00002874

Trial Description


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.

Further Study Information


  • 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.

Eligibility Criteria


  • 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



  • Any age

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • More than 10 years


  • 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


  • Bilirubin normal
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 2.5 times normal


  • Creatinine no greater than 2 times normal


  • No other malignancy within the past 5 years except basal or squamous cell skin cancer or adequately treated invasive cancers


Biologic therapy:

  • No prior biologic therapy for prostate cancer


  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • No prior adjuvant hormonal therapy
  • Prior neoadjuvant hormonal therapy allowed


  • No prior radiotherapy for prostate cancer


  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
  • Southwest Oncology Group
  • NRG Oncology
William U. Shipley, Study Chair
H. Barton Grossman, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00002874
ClinicalTrials.gov processed this data on March 30, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.