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Summary

for males
at San Francisco, California and other locations
study started

Description

Summary

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.

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

Details

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.

Keywords

Prostate Cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer recurrent prostate cancer Bicalutamide

Eligibility

For males

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

Locations

  • Saint Agnes Cancer Center
    Fresno, California, 93720, United States
  • California Cancer Center
    Fresno, California, 93729-5100, United States
  • CCOP - Bay Area Tumor Institute
    Oakland, California, 94609-3305, United States
  • Sutter Health West Cancer Research Group
    Greenbrae, California, 94904, United States
  • Mount Diablo Medical Center
    Concord, California, 94524-4110, United States
  • O'Connor Hospital
    San Jose, California, 95128, United States
  • David Grant Medical Center
    Travis Air Force Base, California, 94535, United States
  • CCOP - Santa Rosa Memorial Hospital
    Santa Rosa, California, 95403, United States
  • Radiation Oncology Center - Sacramento
    Sacramento, California, 95816, United States
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California, 90025-1781, United States
  • Huntington Cancer Center
    Pasadena, California, 91105, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California, 90033-0804, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010-3000, United States
  • Cancer Care Center
    Pomona, California, 91767, United States
  • Veterans Affairs Medical Center - Long Beach
    Long Beach, California, 90822, United States
  • Loma Linda University Medical Center
    Loma Linda, California, 92354, United States
  • CCOP - Southern Nevada Cancer Research Foundation
    Las Vegas, Nevada, 89106, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Radiation Therapy Oncology Group
ID
NCT00002874
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017