Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bicalutamide; estramustine phosphate sodium; etoposide; flutamide; paclitaxel; Luteinizing hormone releasing hormone [LHRH] agonist; Radiation therapy; warfarin
Intervention description: Administered orally at a dose of one 50mg tablet per day. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.; 280 mg three times a day for 14 days and repeated every 3 weeks for 4 cycles; 50 mg/m^2 in divided doses b.i.d. for 14 days and repeated every 3 weeks for 4 cycles; Administered orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg. Begins 8 weeks prior to radiotherapy and continues throughout radiotherapy.; 135 mg/m^2 given as a 1-hour infusion (on day 2 of each cycle) and repeated every 3 weeks for 4 cycles; Releasing hormone agonists (such as leuprolide, goserelin, buserelin, triptorelin) will be given for 4 months; Radiation will begin 8 weeks following the initiation of hormone administration: 46.8 Gy to the regional lymphatics followed by a 23.4 Gy boost to the prostate to bring the total dose to the prostate to 70.2 Gy. Daily tumor doses will be 1.8 Gy per day, 5 days per week x 7-8 weeks.; To keep international normalized ratio (INR) > 1.5 and < 2.5; begins with the start of chemotherapy and will be given continuously until 4 weeks after the end of the fourth cycle of chemotherapy
Intervention MeSH terms: Paclitaxel; Etoposide; Bicalutamide; Flutamide; Estramustine; Warfarin; Hormones; Prolactin Release-Inhibiting Factors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 397.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy
      may fight prostate cancer by reducing the production of androgens. Radiation therapy uses
      high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to
      stop tumor cells from dividing so they stop growing or die. It is not yet known whether
      hormone therapy plus radiation therapy is more effective with or without combination
      chemotherapy for prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus
      radiation therapy with or without combination chemotherapy in treating patients who have
      prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven prostate cancer at high risk for relapse as determined by either
             of the following:

               -  Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T
                  stage)

               -  Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100
                  ng/mL

          -  Negative lymph nodes

          -  No metastatic disease

        PATIENT CHARACTERISTICS:

        Age:

          -  Over 18

        Performance status:

          -  Zubrod 0 or 1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  White blood cell (WBC) count of at least 3,000/mm^3

          -  Platelet count at least 130,000/mm^3

          -  Hemoglobin at least 11.4 g/dL

        Hepatic:

          -  Aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

        Renal:

          -  Creatinine no greater than 2.5 mg/dL

        Other:

          -  No other invasive cancer within the past 5 years except superficial nonmelanomatous
             skin cancer

          -  No major medical or psychiatric illness that would preclude study participation

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  At least 5 years since prior chemotherapy

        Endocrine therapy:

          -  At least 60 days since prior finasteride for prostatic hypertrophy

          -  At least 90 days since prior testosterone

          -  No more than 30 days since initiation of prior pharmacologic androgen ablation for
             prostate cancer

        Radiotherapy:

          -  No prior pelvic radiotherapy

          -  No concurrent intensity-modulated radiotherapy

        Surgery:

          -  No prior radical prostatectomy

          -  No prior cryosurgery for prostate cancer

          -  No prior orchiectomy