Principal Investigator: Christopher Warlick, MD, PhD, Assistant Professor, University of Minnesota

One potential contribution to the disparity in prostate cancer outcomes in AA men is that many tests that guide management decisions have not been validated among AA men. Our hypothesis is that the Oncotype Dx prostate cancer assay performs differently in AA and Caucasian men in its ability to predict
adverse pathology from prostate biopsy specimens.

Our specific aims include:
Specific Aim 1: To determine the expression patterns of genes in the GPS score, as well as the distribution of GPS scores in
biopsy specimens from AA men in NCCN very low, low and intermediate risk groups.

Specific Aim 2: To determine the performance of the GPS score obtained from prostate biopsy specimens for identification of adverse pathology including the presence of dominant pattern 4 or 5, or extracapsular extension in AA men.

Specific Aim 3: To determine the ability of the Oncotype DX assay performed on biopsy specimens in combination with the Cancer of the Prostate Risk Assessment post-surgical (CAPRA-s) nomogram to predict PSA recurrence following radical prostatectomy.

Specific Aim 4: To conduct focus groups to determine attitudes toward and identify potential barriers to the use of genomic tests in AA men.

We will obtain prostate biopsy and radical prostatectomy specimens from 100 AA men from 3 institutions and perform the Oncotype DX assay on biopsy specimens obtaining a GPS score for each. We will compare the performance of the test as outlined above to historical values from predominantly Caucasian cohorts used in the validation studies and in the early clinical experience of the test.

This information will be vital in ensuring the appropriate use of this test in AA men and may provide proof of principle that such molecular tests for prostate cancer require specific validation in AA men to avoid contributing further to disparate outcomes for AA men with prostate cancer, commensurate with the aims of this RFA.

In addition, we will explore the presence and possible solutions to barriers to the use of genomic tests or
participation in the future validation of such tests in AA men through formal focus groups involving our
community partners the 100 Black Men of America.

Prostate cancer care is moving toward treatments based on molecular signatures of tumors found in individual men. These new tests such as Oncotype DX for prostate require validation in AA as well as Caucasian men as it unclear these tests perform similarly in these two groups of men. Failure to do so may enlarge the disparities and worse outcomes currently endured by AA men with prostate cancer.