Canadian Cancer Trials Group - Tumour Bank
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PRP1B Details
Status: Closed 
Activation Date: 2005JUL29
Closing Date: 2009APR17
Phase: III 

Description: An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product 

Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia. 

Objective: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies. 

Participation: Limited to subjects enrolled on the PRP.1 study. 

Lay Description: The purpose of these studies is to better understand the nature of high grade prostatic intraepithelial neoplasia and to determine how subjects respond to treatment with vitamin E, selenium and soy protein product. 

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