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

Phase 1

Withdrawn

• Conditions: Prostate Cancer

• Registration Number: NCT00005827
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2000-06-02
• Primary Completion: 2003-05
• Study Completion: 2003-05
• Study First Submitted QC: 2004-04-19
• Study First Posted: 2004-04-20
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center, UNC; 🇺🇸 Chapel Hill, North Carolina, United States