Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy
I. To determine differences in prostate tissue steady state concentrations of calcitriol in
participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which
provides 600 mg of genistein) and those receiving placebo.
I. To determine the effect of each intervention arm and resulting prostate tissue levels of
calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily
(QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.
ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28.
Patients then undergo prostatectomy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Tissue levels of calcitriol between the placebo and cholecalciferol/genistein arms
Using the Student t-test. Wilcoxon rank-sum test will be used for comparison.
Up to 35 days
University of Wisconsin Chemoprevention Consortium
United States: Food and Drug Administration
|University of Wisconsin Chemoprevention Consortium||Madison, Wisconsin 53706-1969|