TREATMENT OF HIGH-GRADE, HIGH-STAGE PROSTATE-CANCER WITH ESTRAMUSTINEPHOSPHATE OR DIETHYLSTILBESTROL - A DOUBLE-BLIND-STUDY

Between 1984 and 1989, 197 patients with T1-4 NX, M1, G2-3 or G3 prost ate cancer were randomized to treatment with 560 mg estramustine phosp hate (EMP, Estracyt(R), Emcyt(R)) or 3 mg diethylstilbestrol (DES) per day in a double blind study with stratification on presence or absenc e of cancer pain at start. A total of 194 patients were evaluated for efficacy of therapy. Time to progression (p = 0.054), to treatment fai lure (p = 0.036), cancer-specific survival (p = 0.068) as well as over all survival (p = 0.021) were longer in the DES group. There were more patients with prognostic parameters indicating bad prognosis in the E MP group. This trial was designed to study whether EMP had better effe ct than DES as the primary treatment of high-grade, disseminated prost ate cancer. The results did not confirm this hypothesis. On the contra ry, treatment with DES had relatively good effect on this very aggress ive form of prostate cancer.