Evaluation of the Oncotype DX Test in African-American Men with Prostate Cancer

Christopher Warlicka, Charles Rogersa , Jeff Nixb, Mark Alexanderc, Marc Dall’Erad

aUniversity of Minnesota, bUniversity of Alabama, c100 Black Men of America, dUniversity of California Davis

NIH U54MD008620

Background• Prostate cancer disproportionally affects African-American

(AA) men with higher incidence and mortality

• Several new genomic tests are now available to help make management decisions, but have not been validated on significant numbers of AA men

• It is not clear whether these tests will perform similarly in AA and Caucasian men

• Given mistrust in the health care system, it is unclear if there are any barriers to the use of such tests among AA men

• Despite being severely affected by prostate cancer, AA men participate in prostate cancer research at low levels

Objectives• To evaluate the performance of the Oncotype

DX test in AA men with prostate cancer

• To determine if barriers to the use of genomic tests exist among AA men

• To define barriers and solutions to participation in prostate cancer research among AA men and to determine community based priorities for future prostate cancer research

Specific Aims• 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.

Overview• Evaluation of the Oncotype DX prostate cancer risk stratification test in

African-American men

• Test 100 Gleason 6 or 7 prostate biopsy specimens with paired prostatectomy specimens

• Evaluate the performance of the Oncotype DX test in AA men with prostate cancer

• Focus groups

• Conduct 2 rounds of focus groups in Minneapolis, Birmingham, Northern California

• Focus Group 1: Determine barriers to the use of genomic testing

• Focus Group 2: Evaluate involvement of AA men in prostate cancer research

• Barriers to participation

• Research priorities

• Attitudes toward PSA testing

Oncotype DX

• Identify men from 2000 to 2010(4) with Gleason 6 or 7 who underwent prostatectomy

• UMN: 6 specimens identified

• UAB: Approximately 30 specimens identified

• UC Davis: anticipate 20 specimens

Challenges and Solutions

• Delay in initiation of specimen search

• Fewer specimens identified than anticipated due to increased use of active surveillance over study period and possibly due to where AA men seek care

• Solution: include additional sites to procure specimens

• Time constraints: industry collaborator anxious to finish project

• Money: additional funding might be needed for this

Focus Groups

• Focus Group 1: Attitudes toward genomic testing

• Focus Group 2: Attitudes toward prostate cancer research

Focus Group 1• [1] On a white board list both terms “genetic testing” and “genomic

testing”.

• Say, “I’d like to understand more about how you view these terms. What are some words or definitions that you would use to describe each of these terms? I will list the words or definitions on the white board as the group talks about them.”

• [2] Under what conditions would you be willing, or willing to have a family member, undergo genetic or genomic testing?

• [3] Now thinking about prostate cancer in particular …under what conditions would you be willing, or willing to have a family member, undergo genetic or genomic testing?

• [4] What is your opinion about undergoing genetic or genomic testing regarding prostate cancer if it was for a research study instead of directly for care of you or your family member’s prostate cancer?

• [5] What is your opinion about whether African American men should participate in research studies regarding prostate cancer? Why or why not?

• [6] What is your opinion about African Americans participating in medical research studies?

Focus Group 1• Four focus groups have been completed

• Minneapolis: 8 participants

• Birmingham: 7 participants

• Sacramento: 8 participants

• Oakland: 8 participants

• Qualitative data analysis beginning

Focus Group 2

• Three focus groups will be conducted

• Oakland (completed): 15 participants

• Minneapolis: Scheduled for April

• Birmingham: Scheduled for May

Future Directions

• Complete specimen procurement ASAP

• Begin qualitative analysis for Focus Group 1 data

• Complete Focus Group 2 and data analysis

Thank You• Dr. Jeff Nix, UAB

• Dr. Marc Dall’Era, UC Davis

• Dr. Mark Alexander, 100 Black Men of America

• Dr. Charles Rogers, UMN

• …and everyone else who has helped on this project!