Spots Global Cancer Trial Database for Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

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Trial Identification

Brief Title: Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer

Official Title: Phase I Single and Multiple-Dose Safety and Pharmacokinetic Clinical Study of Genistein in Normal Volunteers and in Prostate Neoplasia (Multiple Dose Safety and Pharmacokinetic Clinical Study of Genistein in Prostate Neoplasia)

Study ID: NCT00005827

Conditions

Prostate Cancer

Interventions

genistein

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase I trial to determine the effectiveness of genistein in treating patients who have stage II, stage III, or stage IV prostate cancer.

Detailed Description: OBJECTIVES: I. Determine the safety and pharmacokinetics of genistein in patients with stage II, III, or IV prostate cancer. OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral genistein twice daily. Arm II: Patients receive oral placebo twice daily. Treatment continues for 3 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 6 months.