MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)

Detailed Description

Active surveillance (AS) avoids or delays prostate cancer (PCa) treatment side effects for survivors. Blacks and men of lower socioeconomic status (SES) under-utilize this monitoring approach. Previous work has demonstrated that Genomic Prostate Score assay (GPS) is accurate in detecting adverse pathology at radical prostatectomy in Black and White men eligible for AS. One small study showed that Genomic Prostate Score (GPS) can predict tumor progression in 3 years. ENACT was closed to enrollment in 2019 and there were 200 men eligible for AS of lower SES enrolled into a randomized clinical trial assessing the impact of the GPS on patient treatment choice. AS was chosen by 77% of the participants for primary treatment and 72.1% of them were Black. The ENACT cohort now represents the second largest cohort of Black men on AS (n=112) with a median follow-up of 3 years. Moreover, recruitment took place at a Veterans Administration hospital, a County hospital and a state-funded University medical center serving men from with low rates of private insurance and a range of health literacy levels, thus complementing the data available from most AS cohorts. The long term goal is to reduce PCa over-treatment by improving the safety and acceptability of AS for men at higher risk for aggressive PCa. Multiparametric MRI of the prostate (mpMRI) has similarly been shown to predict tumor progression and Hence, the study will assess the accuracy of GPS for tumor progression, assess the impact of GPS on adherence to AS monitoring, and identify factors affecting AS selection in men of lower SES.

Aim 1. Assess the accuracy of the Genomic Prostate Score in a Black-enriched cohort to identify disease progression while on Active Surveillance over 3 years.

Methods: 66 of the 140 men on AS were randomized to receive the GPS. GPS tests will be performed on the 74 control participants’ biopsies and coordinators will track all of the men for tumor progression (increase in Gleason score) on first AS prostate biopsy (PB) at 12-18 months. Tumor progression will be coded as Yes/No and receiver operating characteristics will be calculated for GPS while controlling for National Comprehensive Cancer Network (NCCN) risk group, age and race.

Aim 2. Compare the degree of adherence with NCCN active surveillance protocol at 18 months in men initially randomized to the GPS Intervention vs. Control group.

Methods: 140 of 200 men elected AS for initial treatment (101 Black/39 non-Black). As of January 2020, 3 men were lost to follow up. The proportion of men completing their surveillance prostate biopsy (PB) will be assessed at 18 months and there will be an assessment of the median number of prostate specific antigen (PSA) tests and digital rectal exams (DREs) completed per year between the 66 men randomized to the GPS on AS and the 74 controls.

Aim 3. Identify the main barriers and facilitators to initial active surveillance selection in a Black-enriched population.

Methods: Aim 3 leverage the clinical trial data and participants. All participants will be administered a survey to identify which factors encouraged or discouraged them from choosing AS, including patient and tumor factors, urologist treatment and decision making preference, and the GPS assay. There will be measures for medical mistrust, social support, employment status, insurance status, transportation and financial concerns, interactions with other PCa patients, and fear of job loss, side effects, surgery or of radiotherapy.