Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
This study has been completed.
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00078923
First received: March 8, 2004
Last updated: March 12, 2012
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| 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:
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) |
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
Investigators
| Principal Investigator: | Omer Kucuk, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
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: | March 12, 2012 |
| 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 May 19, 2013