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 D3 in the growth regulation of prostate cancer. We conducted a phase II clinical trial evaluating calcitriol (1,25(OH)2D3) in patients with hormone refractory prostate cancer. We enrolled 14 patients in this study. 1,25(OH)2D3 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)2D3 given in this manner is inactive in advanced prostate cancer. Dose escalation of oral 1,25(OH)2D3 is limited by hypercalcemia.