Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate

Prostate Cancer Clinical Trial

Official title:

Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078923
• Other study ID #: CDR0000353197
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: March 4, 2014
• Start date: November 2001
• Est. completion date: May 2010

Study information

• Verified date: March 2014
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent or delay the development of early cancer. Soy isoflavones may be effective in delaying the development of early prostate cancer.

PURPOSE: This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer (adenocarcinoma).

Description:

OBJECTIVES:

• Compare blood/prostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy.

• Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens.

• Determine the potential response, in terms of tumor and prostatic intraepithelial neoplasia grade and volume, extraprostatic extension, and serum prostate-specific antigen level, in patients treated with soy isoflavones and in those treated with placebo.

• Determine the safety of soy isoflavone supplementation in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group study. Patients are stratified according to tumor stage (T1c vs T2). Patients are randomized to 1 of 4 treatment arms.

• Arm I (control group): Patients receive oral placebo once daily.

• Arm II: Patients receive oral soy isoflavones and oral placebo once daily.

• Arm III: Patients receive a higher dose of oral soy isoflavones and oral placebo once daily.

• Arm IV: Patients receive a higher dose (higher than arm III) of oral soy isoflavones once daily.

In all arms, treatment continues for 2-6 weeks (depending on the time from study entry to planned surgery) in the absence of unacceptable toxicity. All patients then undergo radical prostatectomy.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 100 patients (25 per treatment arm) will be accrued for this study within 12.5 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Stage T1c or T2

• Disease confined to the prostate gland

• Planning to undergo radical prostatectomy within the next 3-4 weeks

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• ALT and AST less than 2 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2 times ULN

Renal

• Not specified

Other

• Fertile patients must use effective barrier contraception

• Medically cleared for surgery

• No concurrent thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biological therapy for prostate cancer

• No concurrent biological agents

Chemotherapy

• No prior chemotherapy for prostate cancer

• No concurrent chemotherapy

Endocrine therapy

• No prior hormonal therapy for prostate cancer

• No concurrent thyroid hormone replacement medication

• No concurrent hormonal therapy

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• At least 3 months since prior high-dose nutritional supplements

• No concurrent regular use (more than once weekly) of soy products greater than 50 g of soy protein or 50 mg of soy isoflavone

• No concurrent high-dose nutritional supplements

• Standard-dose single multivitamin tablet (e.g., Centrum™) allowed

• No concurrent herbs

• No concurrent soy foods

• No other concurrent isoflavone supplements

• No other concurrent antineoplastic agents

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• soy isoflavones

Procedure:
• neoadjuvant therapy
Prostatectomy or Brachytherapy

Other:
• Placebo
Arm I: 4 placebo capsules Arm II: 3 placebo capsules Arm III: 2 placebo capsules

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative DNA damage as measured by 5-hydroxymethyluridine level		at 3 weeks	No
Primary	Lipid oxidation as measured by 8-isoprostane level		at 3 weeks	No
Secondary	Tumor size, grade, and extension		at 3 weeks	No
Secondary	Prostate-specific antigen and prostatic intraepithelial neoplasia grade		at 3 weeks	No
Secondary	Biomarkers of cell growth, differentiation, and apoptosis		at 3 weeks	No
Secondary	Toxicity as measured by number and grade of adverse events		at 3 weeks	Yes