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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00058266

Enrollment

Registered

2003-04-09

Start date

2002-12-31

Completion date

2009-09-30

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage I prostate cancer, stage II prostate cancer

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.

Interventions

DIETARY_SUPPLEMENTgenistein

Given orally

PROCEDUREconventional surgery

Patients undergo surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026