Prostate Adenocarcinoma Clinical Trial
Official title:
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
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
tissue.
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
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