Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed Any age NCI RTOG-9601 RTOG 96-01, RTOG-R9601, NCT00002874, RTOG-96-01

Special Category: CTSU trial

Objectives

1. 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.
2. 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.
3. 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.
4. Compare each regimen with respect to 5-year and 10-year freedom from progression rates.
5. Compare each regimen with respect to unintended adverse effects on treatment.
6. Allow for subsequent analysis of emerging molecular pathologic predictors of outcome with the prospective collection of paraffin blocks from the radical prostatectomy specimen.

Entry Criteria

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

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

Patient Characteristics:

Age:

• Any age

Performance status:

• Karnofsky 80-100%

Life expectancy:

• More than 10 years

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³
• Hematocrit at least 36%
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin normal
• AST or 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

Expected Enrollment

A total of 810 patients will be accrued for this study within approximately 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

William Shipley, MD, FACR, Protocol chair		Ph: 617-726-8146; 877-726-5130 Email: wshipley@partners.org

Southwest Oncology Group

H. Grossman, MD, Protocol chair		Ph: 713-792-3250; 800-392-1611

Registry Information
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
Trial Start Date		1998-02-15
Registered in ClinicalTrials.gov		NCT00002874
Date Submitted to PDQ		1996-01-10
Information Last Verified		2003-03-27
NCI Grant/Contract Number		CA21661