A comparison of diethylstilbestrol or orchiectomy with buserelin and with methotrexate plus diethylstilbestrol or orchiectomy in newly diagnosed patients with clinical stage D2 cancer of the prostate.

From April 1983 to March 1985, 265 patients with newly diagnosed metastatic prostate cancer were randomized to one of three treatment protocols: (1) diethylstilbestrol (DES) or bilateral orchiectomy, (2) the leutinizing hormone-releasing hormone (LHRH) analog buserelin, or (3) methotrexate plus DES or orchiectomy. In 261 evaluable patients there was no significant difference in survival between the three groups. However, progression-free survival (PFS) was significantly different (P less than 0.0005, log-rank test). Of the possible pairwise comparisons for PFS, two showed significance; buserelin was inferior to DES/orchiectomy (P less than 0.05) and buserelin was inferior to methotrexate plus DES/orchiectomy (P less than 0.0001).

RCT Entities:   Population Interventions Outcomes