Soy Supplementation and Prostate Cancer Prevention
Abstract
This project is conducting a randomized double-blind clinical trial to assess the ability of a soy protein dietary supplement to reduce prostate cancer risk in older men. A total of 120 men (60 white and 60 African-American) aged 50 years or older with high PSA levels but normal prostate biopsies will be randomized into one of two groups (soy protein supplementation with isoflavones or casein protein supplementation). The specific aims are: 1) to determine the impact of the interventions, including changes in clinical (PSA levels and prostate volume) and intermediate (Ki-67, apoptosis, sex-steroid receptors, angiogenesis, antioxidant enzyme expression) markers of prostate cancer risk; 2) to assess soy protein effects on hormone levels, plasma lipids/lipoproteins and blood pressure; and 3) to evaluate changes in health-related quality of life, including urinary symptoms and sexual functioning. This project involves a multidisciplinary team affiliated with the oncology, Epidemiology, health- related quality of life, biostatistics, and nutrition. NCI approved of the CALGB protocol delayed start-up of this study; recruitment has been continuous since March 2000. However, recruitment to this study has been suspended per DOD Human Subjects Protection Office. Limited access status was changed to include all CALGB member institutions in recruitment on November 2001. Eight institutions have opened the protocol.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2003
- Accession Number
- ADA413619
Entities
People
- Electra D. Paskett
Organizations
- Ohio State University