The Impact of a Gene Expression Profile on Treatment Choice and Outcome among Minority Men Newly Diagnosed with Prostate Cancer: A Randomized Trial
Abstract
Background: The problem of how to discriminate patients with prostate cancer who need immediate therapy from those for whom therapy should be deferred or avoided altogether is one of the most important challenges we face as prostate cancer investigators. We contend that PSA (prostate specific antigen) screening saves lives but also recognize that it leads to overdiagnosis and overtreatment, even when used judiciously. Overdiagnosis is likely to persist to some degree even as new screening protocols and technologies become available. The Oncotype DX Prostate Cancer Assay (Genomic Health, Inc., Redwood City, CA) is a gene expression profiling assay that is performed on a patient s biopsy tissue, and the Genomic Prostate Score it provides is intended to be used by the patient and his physician to make a better-informed choice about whether to choose immediate therapy (surgery or radiation typically) or active surveillance, an approach that involves PSA monitoring and repeat biopsies. It is widely believed that active surveillance is underutilized as an approach to reduce overtreatment. While this biomarker assay has recently undergone validation in terms of its ability to predict aggressive prostate cancer, its actual impact on a patient s treatment decisions and psychological well-being remains unknown. This project focuses predominantly on African-American (AA) men, because of their markedly higher risk for aggressive prostate cancer and because it is not clear that the Oncotype DX (ODX) assay will have the same clinical utility for them as it will have in other populations. Aims: We are proposing to conduct a randomized trial to determine the effects of adding the ODX assay to usual counseling on treatment choice and psychological status among predominantly minority men with very low to intermediate risk newly diagnosed prostate cancer. Our endpoints are: (1) Treatment choice: Does adding information from the ODX assay lead more men to adopt active surveillance, thus reducing the incidence of overtreatment for indolent cancer? Is the impact of the assay the same in AA and non-AA men? What other factors influence the effect of the test on treatment choice? (2) Psychological status: Does adding the ODX assay improve perceived risk or fear of a poor outcome, or improve cancer-related mood/anxiety during the stressful period following diagnosis? Is this effect similar in AA and non-AA men? (3) Predictive accuracy: In exploratory analyses, we will add to the data on how accurately the ODX assay predicts adverse pathology in AA men who undergo surgery or repeat biopsy on active surveillance. Method: A total of 240 men with newly diagnosed, non-high risk prostate cancer at three Chicago institutions (University of Chicago, Jesse Brown VA Medical Center, and Stroger Cook County Hospital) will be randomly assigned to receive usual counseling (patient-centered, using standard risk categories) or usual counseling plus the ODX assay. We estimate that 70%-75% of the patients will be AA. Biopsy tissue will be sent to Genomic Health, which will provide the ODX assay at no cost. Urologists will be trained to deliver counseling following standardized precepts. Patients will complete validated questionnaires that evaluate perceived risk/fear and mood/anxiety before and after intervention, and questionnaires on decision conflict and decision regret. The urologist will record his/her preferred treatment for each patient, both before and after a decision has been made. The data analysis will focus on comparing the randomized groups with respect to adoption of active surveillance and on differences in psychological parameters. We will explore various factors in addition to race, such as age, health literacy, comorbidity, and baseline anxiety that might influence the effect of receiving the ODX assay result. Expected Impact: The results from this trial will provide actionable new information that can improve the c
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 04, 2016
- Source ID
- W81XWH1510534
Entities
People
- Adam B Murphy
Organizations
- Northwestern University
- United States Army