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Summary

for males (full criteria)
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 or stage III prostate cancer and elevated prostate-specific antigen (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

Keywords

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

Eligibility

For males

Conditions for Patient Eligibility:

  • The patient on entry will have no clinical evidence of disease by physical exam or by imaging studies. A positive ProstaScint scan alone without a confirmatory biopsy must not be used to exclude a patient. Eligible patients will be those who have undergone a radical prostatectomy (either retropubic or perineal) and pelvic lymphadenectomy(either open or laparoscopic) for carcinoma of the prostate, pathologic stage T3N0, or pT2 pN0 with positive inked resection margin, at least 12 weeks prior to study entry.
  • Pathological T2 patients without positive margins, who are also pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer, are eligible.
  • At entry, the PSA must be between 0.2 and 4.0ng/ml, inclusive.
  • A post-prostatectomy radioisotopic bone scan which was done within 16 weeks prior to entry must reveal no evidence of metastatic disease.
  • Patient must be evaluated by both the radiation oncologist and the urologist prior to entry and judged to be a suitable candidate for radiation and hormonal therapy.
  • Patient must have Karnofsky performance status >= 80.
  • Patients must have a life expectancy in excess of 10 years.
  • Patients must have, within 6 weeks prior to entry, a hemoglobin (Hgb) of >=10 gm, a white blood cell (WBC) count of >= 4000 cells/ml3, a platelet count of >= 100,000 cells/ml3, a serum bilirubin <= the institutional upper limit of normal, a serum serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT)of <= 2.5 times the institutional upper limit of normal, and a serum creatinine of <=2.0 times the institutional upper limit of normal.
  • A post-prostatectomy pelvic computerized tomography (CT) scan, within 16 weeks prior to randomization, must reveal no evidence of metastatic disease.
  • Patients must sign a study-specific informed consent form.
  • Patients with prior invasive cancers are eligible if disease free for at least 5 years; prior or concurrent basal or squamous cell skin cancer is eligible.

Conditions for Patient Ineligibility:

  • Pathologic stage T2 (without positive inked resection margin) or less except as stated in Section 3.1.1.1.
  • Pathologic lymph node stage of pN1 or greater.
  • An entry serum PSA of > 4.0ng/ml.
  • Patients with persistant urinary extravasation after prostatectomy.
  • Patients who have been previously treated with any hormonal therapy after prostatectomy.
  • Patients who have previously been treated with radiation therapy or biologic therapy for prostate cancer.
  • Karnofsky performance status < 80.
  • Treatment start > 4 weeks after randomization.
  • Prior chemotherapy for any reason.

Locations

  • UCSF Cancer Center and Cancer Research Institute
    San Francisco, California, 94143-0128, United States
  • 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
July 18, 2017