Text Size

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

This study has been terminated.
(Data Monitoring Committee cited poor accrual.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00058266
First received: April 7, 2003
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Dietary Supplement: genistein
Procedure: conventional surgery
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)

Resource links provided by NLM:

Drug Information available for: Genistein
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Toxicity [ Time Frame: At surgery & monthly thereafter during treatment (3 mos) ] [ Designated as safety issue: Yes ]
  • Decrease in prostate-specific antigen-positive cells [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Alteration in cell morphology [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2002
Study Completion Date: September 2009
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058266

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Raymond C. Bergan, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00058266     History of Changes
Other Study ID Numbers: NU 00U7, NU-00U7
Study First Received: April 7, 2003
Last Updated: July 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genistein
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013