NCT00058266

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

April 7, 2003

Last Update Submit

July 10, 2012

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage II prostate cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

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: genisteinProcedure: conventional surgery

Group B

EXPERIMENTAL

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

Dietary Supplement: genisteinProcedure: conventional surgery

Interventions

genisteinDIETARY_SUPPLEMENT

Given orally

Group AGroup B
conventional surgeryPROCEDURE

Patients undergo surgery

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IsoflavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Raymond C. Bergan, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

December 1, 2002

Primary Completion

November 1, 2006

Study Completion

September 1, 2009

Last Updated

July 19, 2012

Record last verified: 2012-07

Locations

US(5)