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

July 10, 2012 updated by: Northwestern University

A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60611
        • Veterans Affairs Medical Center - Lakeside Chicago
      • Evanston, Illinois, United States, 60201-1781
        • Evanston Northwestern Healthcare - Evanston Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of localized prostate cancer

    • Diagnosed within the past 6 months
    • T1 or T2 disease
    • Gleason score 5-8
    • Prostate-specific antigen no greater than 20 ng/mL
  • Radical prostatectomy planned

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 2 years

Hematopoietic

  • Hemoglobin greater than 9.0 g/dL
  • Platelet count greater than 100,000/mm^3
  • Absolute neutrophil count greater than 1,000/mm^3

Hepatic

  • SGPT and SGOT less than 3 times normal
  • Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)

Renal

  • Creatinine less than 2.0 mg/dL

Cardiovascular

  • No venous thrombosis within the past year

Other

  • Patients must use effective barrier contraception
  • No other medical condition that would preclude study therapy
  • No known soy intolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No concurrent hormonal therapy for prostate cancer

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics

Other

  • No concurrent soy supplements
  • No concurrent foods high in genistein
  • No concurrent active therapy for neoplastic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Dietary supplement: genistein
Given orally
Procedure: conventional surgery
Patients undergo surgery
Experimental: Group B
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Dietary supplement: genistein
Given orally
Procedure: conventional surgery
Patients undergo surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Raymond C. Bergan, MD, Robert H. Lurie Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 00U7
  • NU-00U7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe