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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
genistein
conventional surgery
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage II prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • Evanston Northwestern Healthcare - Evanston Hospital
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • University of Washington School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Toxicity
Decrease in prostate-specific antigen-positive cells
Alteration in cell morphology

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
July 10, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058266
Brief Title
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
Official Title
A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Data Monitoring Committee cited poor accrual.
Study Start Date
December 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage II prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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).
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
genistein
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Patients undergo surgery
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
At surgery & monthly thereafter during treatment (3 mos)
Title
Decrease in prostate-specific antigen-positive cells
Time Frame
At time of surgery
Title
Alteration in cell morphology
Time Frame
At time of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond C. Bergan, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northwestern Healthcare - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Ingalls Cancer Care Center at Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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