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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00058266
• Other study ID #: NU 00U7
• Secondary ID: NU-00U7
• Status: Terminated
• Phase: Phase 2
• First received: April 7, 2003
• Last updated: July 10, 2012
• Start date: December 2002
• Est. completion date: September 2009

Study information

• Verified date: July 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 2009
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• genistein
Given orally

Procedure:
• conventional surgery
Patients undergo surgery

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois
United States	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		At surgery & monthly thereafter during treatment (3 mos)	Yes
Primary	Decrease in prostate-specific antigen-positive cells		At time of surgery	No
Primary	Alteration in cell morphology		At time of surgery	No