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Phase II Study of 1-Hydroxyvitamin D₂ in the Treatment of Advanced Androgen-independent Prostate Cancer¹

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792

Purpose: In this single institution Phase II trial, we evaluated the efficacy of the vitamin D analogue, 1-OH-D₂, in patients with advanced hormone-refractory prostate cancer.

Experimental Design: The patients initially received 1-OH-D₂ at 12.5 µg p.o. every day, which was dose adjusted for hypercalcemia. Given the cytostatic nature of the drug, the primary study end point was progression-free survival for a minimum of 6 months. The secondary end point was further characterization of drug toxicity.

Results: A total of 26 patients was enrolled. Using the intent-to-treat population, stable disease was seen for an average of 19.2 weeks (median 12 weeks, range 3–108 weeks). Twenty patients were evaluable for response. The one patient that achieved disease stabilization for >2 years elected to come off-study because of patient preference. His last disease evaluation showed no evidence of progression. No objective responses were seen. Previous and ongoing clinical observations strongly imply that PSA could be a misleading surrogate marker for clinical effect with this type of drug. Therefore, prostate-specific antigen was not used as a marker for disease response. Toxicity was as expected with mild hypercalcemia and associated symptoms like constipation and prerenal azotemia seen in some patients. Six (30%) evaluable patients experienced stable disease for >6 months, suggesting possible cytostatic activity.

Conclusion: The results of this and other trials suggest further clinical investigation in this disease with vitamin D analogues alone or in combination with other agents, such as chemotherapy, should be pursued.

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