Phase II trial of oral 1,25-dihydroxyvitamin D (calcitriol) in hormone refractory prostate cancer.

Epidemiologic and experimental data support a role for 1,25-dihydroxyvitamin D(3) in the growth regulation of prostate cancer. We conducted a phase II clinical trial evaluating calcitriol (1,25(OH)(2)D(3)) in patients with hormone refractory prostate cancer. We enrolled 14 patients in this study. 1,25(OH)(2)D(3) was initiated at a daily oral dose of 0.5 μg and escalated to 1.5 μg daily. No objective responses were observed. However, in two patients decreases of 25% and 45% in prostate specific antigen levels were seen. Hypercalcemia was the predominant toxicity. We conclude that 1,25(OH)(2)D(3) given in this manner is inactive in advanced prostate cancer. Dose escalation of oral 1,25(OH)(2)D(3) is limited by hypercalcemia.