Trial Information

Assessment of SNP Genotypes in Men With Prostate Cancer

OBJECTIVES:

- Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients
with prostate cancer, their affected siblings, and an unaffected healthy population
(control).

- Determine the age of onset of prostate cancer in affected probands and affected
siblings.

- Determine the penetrance or likelihood that given SNPs will result in disease in
affected siblings based upon Mendelian genetics.

- Determine the odds ratio of developing prostate cancer in the presence of SNPs.

- Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study
enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or
androgen-ablation therapy with chemotherapy, and correlate them with disease
progression (i.e., androgen independence).

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
ethnicity, age at diagnosis, and Gleason score.

Patients, their affected siblings, and healthy participants (controls) undergo collection of
blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide
polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and
biographical data.

PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy
participants (controls) will be accrued for this study.