Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy

Phase 2

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00058266
• Lead Sponsor: Northwestern University

Brief Summary

RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.

Detailed Description

OBJECTIVES:

* Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.

* Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.

* Determine the quality of life of patients treated with this drug.

OUTLINE: Patients receive 1 of 2 treatment regimens.

* Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).

* Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.

Quality of life is assessed at baseline and at 1 and 3 months after surgery.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Primary Completion: 2006-11
• Study Completion: 2009-09
• Disposition First Submitted: 2011-05-19
• Disposition First Submitted QC: 2011-05-19
• Disposition First Posted: 2011-05-23
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Toxicity	At surgery & monthly thereafter during treatment (3 mos)
Decrease in prostate-specific antigen-positive cells	At time of surgery
Alteration in cell morphology	At time of surgery

Trial Locations

Locations (5)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago; 🇺🇸 Chicago, Illinois, United States

Evanston Northwestern Healthcare - Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Ingalls Cancer Care Center at Ingalls Memorial Hospital; 🇺🇸 Harvey, Illinois, United States

University of Washington School of Medicine; 🇺🇸 Seattle, Washington, United States