Absence of antitumor activity with prednisone in patients with progressive androgen-independent prostate carcinoma.

Corticosteroids are reported to have antitumor activity in patients with androgen-independent prostate carcinoma (AIPCa). This trial, a phase II trial of daily oral prednisone 10 mg four times per day for 56 consecutive days, was designed to confirm this finding. From November 1989 to September 1992 16 patients were enrolled in the study. Baseline tumor measurements were taken upon enrollment and re-evaluated at completion of 56 days. If the patient was responding or stable, a maintenance schedule of 5 mg four times per day was resumed until unacceptable toxicity was reached or tumor growth progressed. Antitumor activity was assessed by the decline in the serum level of prostate specific antigen. Entry criteria included strict evidence for progressive AIPCa, tumor growth associated with castrate testosterone level below 50 ng/dl, and adrenal cortical function tests. Patients continued hormone therapy that induced castrate testosterone level. Two patients required early cessation of therapy secondary to symptomatic tumor progression. Of the remaining 14 patients, no responses were seen,. Four (29%) of 16 patients had transient improvement in performance status. No hematologic toxicity was observed. Nonhematologic toxicity was mild and manageable, consisting of fluid retention and metabolic laboratory abnormalities. Suppressive effect of adrenal cortical function was demonstrated in patients, measured by a decrease in serum levels of dehydroepiandrosterone and dehydroepiandrosterone sulfate. Our results show that corticosteroids have no significant antitumor activity in patients with true progressive AIPCa.