Mitomycin C for metastatic prostate cancer: Final analysis of a randomizedtrial

Background. Almost all patients that undergo hormonal manipulation for meta static prostate cancer will ultimately progress because of hormone resistan ce. Therefore we assessed the effect of early addition of intravenous Mitom ycin C to orchiectomy in patients with newly diagnosed metastatic prostate cancer. Patients and Methods. 178 patients with histologically proven and p reviously untreated metastatic prostate cancer were included in a prospecti ve, randomized multicenter trial. Randomization was done centrally between orchiectomy alone and orchiectomy with Mitomycin C. 148 patients were evalu able. Results. At the final analysis 139 patients have deceased. The remain ing 9 patients ale still alive, but all present progression. There was no s tatistically significant difference in the real time to progression, or in the estimated cancer related and overall survival between both groups. Mean time to progression was 29 months in group 1 (orchiectomy alone), and 26 m onths in group 2 (orchiectomy and Milomycin C) (p=0.64). Mean time to cance r related death was 32 months and mean overall survival was 31 months in bo th groups. Conclusions. Mitomycin C has no beneficial effect when used in c onjunction to orchiectomy in patients with newly diagnosed metastatic prost ate cancer