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

Sponsor:	Barbara Ann Karmanos Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:	NCT00078923

Purpose

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).

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: soy isoflavones Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:

Oxidative DNA damage as measured by 5-hydroxymethyluridine level at 3 weeks [ Designated as safety issue: No ]
Lipid oxidation as measured by 8-isoprostane level at 3 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor size, grade, and extension at 3 weeks [ Designated as safety issue: No ]
Prostate-specific antigen and prostatic intraepithelial neoplasia grade at 3 weeks [ Designated as safety issue: No ]
Biomarkers of cell growth, differentiation, and apoptosis at 3 weeks [ Designated as safety issue: No ]
Toxicity as measured by number and grade of adverse events at 3 weeks [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	November 2001
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078923

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Omer Kucuk, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Micheal Cher, Wayne State University / Karmanos Cancer Institute
ClinicalTrials.gov Identifier:	NCT00078923 History of Changes
Other Study ID Numbers:	CDR0000353197, P30CA022453, WSU-C-2418
Study First Received:	March 8, 2004
Last Updated:	June 28, 2011
Health Authority:	United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:

stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 12, 2012