Trial Information

Randomized Placebo-Controlled, Double-Blind Study Of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer

PRIMARY OBJECTIVES:

I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3
supplementation (cholecalciferol) in patients with localized, histologically proven
adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever
and have chosen expectant management.

SECONDARY OBJECTIVES:

I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA
following vitamin D3 supplementation.

II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

TERTIARY OBJECTIVES:

I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the
study population.

II. To evaluate relationship between CYP24, 27B1, SNPs and serum 25(OH) vitamin D response
to oral D3 supplementation.

III. To assess the changes in functional assessment in response to 25(OH) vitamin D
supplementation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cholecalciferol orally (PO) once daily for 9 months in the absence
of disease progression or unacceptable toxicity. After a wash-out period of 3 months,
patients then receive placebo PO once daily for 9 months in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive placebo PO once daily for 9 months in the absence of disease
progression or unacceptable toxicity. After a wash-out period of 3 months, patients then
receive cholecalciferol PO once daily for 9 months in the absence of disease progression or
unacceptable toxicity.