Dedicated resources for veteran clinical trial participation: The Prostate Cancer Analysis for Therapy Choice (PATCH) program.

Abstract

5040 Background: The Veterans Affairs (VA) hospital system is the most extensive integrated healthcare system in the United States. It serves 9.1 million Veterans and has over 170 healthcare centers and 1,193 outpatient sites. Traditionally, clinical trial access has been limited at the VA. The Prostate Cancer Foundation (PCF) and the VA worked together to create the Precision Oncology Program for Cancer of Prostate (POPCaP) within the VA Healthcare System. By 2021, they had funded 21 Centers of Excellence. The program not only strived to bring cutting-edge clinical trials to Veterans but also sought to develop careers for VA investigators and encourage clinical trial participation by a more diverse group of men. Methods: PCF and VA-funded sites paid for genomic testing and established clinical trial infrastructure. PATCH developed centralized clinical trial resources- biostatistics, scientific advisory committees, and young investigator development meetings. PATCH also created a budget working group and hired a research nurse to help open complicated investigator-sponsored studies. POPCaP/PATCH provided two monthly meetings for investigators to discuss their research and for industry partners to review trials and drugs in the pipeline. Here, we report on the change in Veteran participation in clinical trials and the demographics of this population from December 2022 to October 2024. Results: Since the development of POPCaP/PATCH, Veteran participation in clinical research has rapidly increased from 100 to 400 men enrolled in clinical trials. The number of clinical trials increased from eight clinical trials to 21. Using an existing database containing genomic results, it enrolled patients in trials requiring specific genomic mutations (e.g., MSI-H, BRCA2). We efficiently screened patients for clinical trials, and more than half of those screened enrolled in trials (60%). Patients of different races and ethnicities participated- white 52.6%, black 36.1%, Hispanic/Latino 4.9%, Asian 2.2%, Native American 1.7%, unknown 2.5%. VA stations opened all phases of clinical trials. Through collaboration with other specialties, interventions included targeted oral therapies, immunotherapies, chemotherapies, radiation, and radiopharmaceuticals. Conclusions: The VA has dramatically increased clinical trial opportunities and participation over the past two years. We used VA databases of genomic results to enroll patients in studies with restrained eligibility requirements, such as the presence of microsatellite instability (3%). Sixty percent of patients screened for studies ultimately enrolled in those studies. The diversity of VA trials relative to other US prostate cancer trials makes the results of VA studies more generalizable to the US population.