A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate

Fecha de inicio: 1 de agosto de 1996

DISEASE CHARACTERISTICS: Histologically proven acinar adenocarcinoma of the prostate Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous "definitive" local therapy No CNS metastases No histologic subtypes, such as pure ductal or any component of small cell carcinoma Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place) PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 3 years Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL Transaminase no greater than 4 times upper limit of normal Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No evidence of bifascicular block on EKG No evidence of active ischemia on EKG No prior history of transient ischemic attack No evidence of congestive heart failure Other: No active peptic ulcer disease No regular use of antacid or H2 blockers No known or predicted achlorhydria No concurrent use of terfenadine, astemizole, omeprazole, or cisapride No second malignancy unless curatively treated No history of deep venous thrombosis No history of pulmonary embolism No serious co-morbidity HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic systemic therapy Endocrine therapy: Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary No androgen deprivation therapy within 1 year prior to study Radiotherapy: No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation) Prior definitive radiotherapy to the prostate and/or one metastatic site allowed At least 8 weeks since radiotherapy to the pelvis At least 3 weeks since radiotherapy to a single metastatic site Surgery: Prior prostatectomy allowed Other: No concurrent anti-anginal therapy or aggressive anticoagulants