Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of combination vitamin-E, soy, and selenium.

Abstract

PURPOSE:

High-grade prostatic intraepithelial neoplasia (HGPIN) is a putative precursor of invasive prostate cancer (PCa). Preclinical evidence suggests vitamin E, selenium, and soy protein may prevent progression of HGPIN to PCa. This hypothesis was tested in a randomized phase III double-blind study of daily soy (40 g), vitamin E (800 U), and selenium (200 μg) versus placebo.

PATIENTS AND METHODS:

Three hundred three men in 12 Canadian centers were analyzed. The main eligibility criterion was confirmed HGPIN in at least one of two biopsies within 18 months of random assignment. Treatment was administered daily for 3 years. Follow-up prostate biopsies occurred at 6, 12, 24, and 36 months postrandomization. The primary end point was time to development of invasive PCa. Kaplan-Meier plots and log-rank tests were used to compare two treatment groups for this end point.

RESULTS:

For all patients, the median age was 62.8 years. The median baseline prostate-specific antigen (PSA; n = 302) was 5.41 ug/L; total testosterone (n = 291) was 13.4 nmol/L. Invasive PCa developed among 26.4% of patients. The hazard ratio for the nutritional supplement to prevent PCa was 1.03 (95% CI, 0.67 to 1.60; P = .88). Gleason score distribution was similar in both groups with 83.5% of cancers graded Gleason sum of 6. Baseline age, weight, PSA, and testosterone did not predict for development of PCa. The supplement was well tolerated with flatulence reported more frequently (27% v 17%) among men receiving micronutrients.

CONCLUSION:

This trial does not support the hypothesis that combination vitamin E, selenium, and soy prevents progression from HGPIN to PCa.

• Authors: Neil E Fleshner, Linda Kapusta, Bryan Donnelly, Simon Tanguay, Joseph Chin, Karen Hersey, Anne Farley, Ken Jansz, D Robert Siemens, Kiril Trpkov, Louis Lacombe, Martin Gleave, Dongsheng Tu, Wendy R Parulekar
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 29 Issue 17 Pg. 2386-90 (Jun 10 2011) ISSN: 1527-7755 [Electronic] United States
• PMID: 21537051 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Soybean Proteins
• Vitamin E
• Testosterone
• Prostate-Specific Antigen
• Selenium

Topics

• Disease Progression
• Disease-Free Survival
• Double-Blind Method
• Humans
• Male
• Middle Aged
• Patient Compliance
• Prostate-Specific Antigen (blood)
• Prostatic Intraepithelial Neoplasia (complications)
• Prostatic Neoplasms (epidemiology, mortality, prevention & control)
• Selenium (administration & dosage, adverse effects)
• Soybean Proteins (administration & dosage, adverse effects)
• Testosterone (blood)
• Vitamin E (administration & dosage, adverse effects)