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
Patients will be randomized to either receive placebo or a single dose of cholecalciferol and daily genistein (G-2535). This study is looking to establish if these drugs are beneficial in men with early stage prostate cancer undergoing prostatectomy.
-Diagnosis of prostate cancer confined to the prostate. -Must have prostatectomy as part of the planned course of treatment. -No prior treatment for prostate cancer. -Must not take NSAIDs except low dose asprin during the course of the study. -Must not take supplements or food with soy or any vitamin supplements while on study. -Must not be taking Finasteride or Dutasteride. -Must not have a history of thyroid disease or sacroidosis.
Vitamin D3 (a single dose of cholecalciferol 200,000 IU, taken as four 50,000 IU capsules) will be administered by mouth on Day 1 only and two capsules of G-2535 to provide genistein 600mg taken together, by mouth daily for 21-28 days. Patients will be randomized to take these drugs or placebo tablets. This is taken leading up to prostatectomy with the last dose of G-2535 taken the day before surgery (approximately 12 hours before last blood draw).
06/17/2013 04:02 AM