Phase II trial of tamoxifen in metastatic carcinoma of the prostate

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Abstract
Fifty-one patients with advanced metastatic carcinoma of the prostate were treated with the antiestrogen tamoxifen. Thirty-eight of these patients were refractory to prior hormonal manipulation with estrogens and/or orchiectomy, and five (13%) achieved an objective response (partial regression or stable disease using the National Prostate Cancer Project criteria). Median survival of the responders was significantly longer than that of the nonresponders (P < 0.05). An additional 13 patients who had not previously received hormonal manipulation were treated with tamoxifen; one partial response and three disease stabilizations were noted. Response was separately evaluated for 15 patients with objectively measurable lesions using standard Phase II response criteria. Only 1/15 (7%) partial response and 3/15 (20%) disease stabilizations were documented. Subjective benefit in terms of significant pain relief was noted in 17/50 (34%) of patients. Toxicity was mild, but two possible “tumor flares” were noted. These results do not support the continued investigation of tamoxifen in advanced carcinoma of the prostate.