Expanding an Active Surveillance Cohort to Improve Survivorship for Black Men with Favorable-Risk Prostate Cancer
Abstract
Background: We randomized 200 men with very low to intermediate risk prostate cancer into the ENACT clinical trial from 2016-2019 to study the impact of the Oncotype DX assay on treatment choice in three safety net hospitals. Overall, 104 men received Oncotype DX assay and 96 controls did not receive the assay (a risk assessment tool) right after being newly diagnosed with favorable risk prostate cancer. For this proposal, we will recruit 200 men into the Black and Low-income men considering Active Surveillance for Treatment (BLAST) study and give them the Oncotype DX assay and multiparametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Our long-range goal is to improve the safety and uptake of AS in Black and lower socioeconomic status men for improved survivorship. Recent studies highlight significant promise for multiparametric MRI and Oncotype DX Prostate Cancer Assay as tools to help risk stratify men on AS. Both tests can identify men with aggressive cancer in their prostate that was missed on their diagnostic prostate biopsy. They may provide complementary data as well. Adherence to monitoring with repeat prostate biopsies is vital for the safety of AS because the initial biopsy underestimates the tumor aggressiveness in 30% of men. Given the risk data provided by these modalities and the low adherence to monitoring common in Blacks and men served in public hospitals, our goal is to determine whether these tools can improve safety via improved risk assessment and patient adherence to monitoring. We will address this goal with the following Specific Aims. Specific Aims: Aim 1. Compare the degree of adherence with the NCCN AS protocol at 18 months in men who received MRI+GPS, GPS-only, or neither before embarking on AS. Aim 2. Compare the ability of MRI+GPS, GPS-only or neither to predict tumor reclassification/progression over 18 months. Aim 3. Identify the main barriers and facilitators to active surveillance selection in men undergoing risk assessment. Between the ENACT and BLAST study, we will have three groups of men who all received their NCCN prostate cancer risk group and will have received both Oncotype DX & MRI, Oncotype DX alone, or neither test. We can compare the impact of having 0, 1, or 2 risk assessment tests on patient’s adherence to AS monitoring protocols over 18 months. We will determine whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death, especially in high risk Black men. In Aim 2, we can use the ENACT control group and intervention group and the BLAST study cohort to determine the impact of the Genomic Prostate Score from the Oncotype DX assay and the MRI PIRADS Score in decreasing the percentage of men who have an increase in Gleason grade group (GG) on surveillance prostate biopsy (biopsy reclassification) in 18 months. We can measure progression/biopsy reclassification through increased GG or change in prostate digital rectal examination findings (clinical stage) or rapid increases in PSA (increased PSA doubling time). This will allow doctors to categorize the patient as risky for AS upfront and encourage men with truly low risk PCa to choose surveillance. Last, in Aim 3, we will see how Black and lower socioeconomic status men in BLAST rank the importance of these tests among a multitude of clinical, social, financial, and interpersonal influences on their cancer treatment choice. By patient rankings, we will identify the most critical decision-making factors that can be used to encourage increased selection of AS. Our proposal addresses two of DOD’s overarching challenges, which are to improve the quality of life for survivors of prostate cancer via increased AS selection and to reduce lethal prostate cancer in people of African descent, Veterans, and high-risk and underserved popu
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110850
Entities
People
- Peter H Gann
Organizations
- United States Army
- University of Illinois at Chicago