Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NU-00U7 NCT00058266

Objectives

1. Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.
2. Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.
3. Determine the quality of life of patients treated with this drug.

Entry 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

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

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/mm³
• Absolute neutrophil count greater than 1,000/mm³

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

Expected Enrollment

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

Outcomes

Toxicity
Decrease in prostate-specific antigen-positive cells
Quality of life

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Raymond Bergan, MD, Protocol chair		Ph: 312-908-5284 Email: r-bergan@northwestern.edu

Registry Information
Official Title		A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)
Trial Start Date		2002-12-06
Registered in ClinicalTrials.gov		NCT00058266
Date Submitted to PDQ		2003-02-25
Information Last Verified		2009-01-07
NCI Grant/Contract Number		CA60553

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