GOSERELIN VERSUS ORCHIECTOMY IN THE TREATMENT OF ADVANCED PROSTATE-CANCER - FINAL RESULTS OF A RANDOMIZED TRIAL

Objectives. To compare the efficacy and safety of goserelin and orchie ctomy in patients with Stage D2 prostate cancer. Methods. A randomized , open, multicenter study was conducted in 283 patients. Patients were allocated to goserelin, 3.6 mg every 28 days, or to orchiectomy. Stud y end points were endocrine response, objective response, time to trea tment failure, survival, and tolerability. Objective response was base d on modified criteria of the National Prostate Cancer Project. Result s. Serum testosterone decreased from baseline to castrate levels by we ek 4 in each group and remained below castrate levels thereafter. Acid phosphatase and alkaline phosphatase concentrations also decreased in each group. The goserelin and orchiectomy groups had similar results for objective response (82% versus 77%) and had similar median times t o treatment failure (52 versus 53 weeks) and survival (119 versus 136 weeks). No significant interactions between treatments and prognostic factors were observed, Adjusting for baseline testosterone concentrati on had no effect on survival outcome. Race had no influence on outcome or efficacy end points. Common adverse events in both groups were pai n, hot flushes, and lower urinary tract symptoms. Conclusions. Goserel in is well tolerated and as effective as orchiectomy in patients with Stage D2 prostate cancer.