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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: bicalutamide
• Radiation: low-LET cobalt-60 gamma ray therapy
• Radiation: low-LET photon therapy

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:

• 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
• 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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radiation Therapy Oncology Group

Overall Clinical Trial Officials and Contacts

William U. Shipley, MD, FACR Study Chair Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002874

Study ID Number: CDR0000065158

ClinicalTrials.gov Identifier: NCT00002874

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database