Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bicalutamide; radiation therapy; placebo
Intervention description: One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.; 64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.; One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
Intervention MeSH terms: Bicalutamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 840.0
Sex: Male
Healthy volunteers: No
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; recurrent prostate cancer

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.
    

Eligibility criteria:

        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.