Treatment of Advanced Prostatic Cancer with Parenteral Cyproterone Acetate: A Phase III Randomised Trial*

Abstract
Patients (42) with previously untreated T3/4 N1-4 M0/1 prostatic adenocarcinoma were treated with either cyproterone acetate (n = 21; 300 mg i.m./wk) or estradiol undecylate (n = 21; 100 mg i.m./mo.) after extensive staging which included open skeletal biopsy and pelvic lymphadenectomy in some cases. Subjective and objective parameters as well as signs of drug toxicity were recorded regularly. Evaluation after 6 mo. showed cyproterone acetate to be more effective in the following respects: the significantly different castration effect as judged by plasma testosterone, the objective voiding pattern and tumor response, with regression of palpable and histologically evaluable local tumor in 16 of 21 patients and side effects and untoward reactions. Thus cyproterone acetate is suggested as a valuable alternative in the treatment of advanced prostatic cancer.

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