Analysis of a pre-screening platform for clinical trials in patients with prostate cancer.

Abstract

e17103 Background: The clinical development process is often delayed by slow patient enrollment. Currently, <5% of oncology patients participate in clinical trials, with significant underrepresentation of diverse populations compared to the general patient demographic. N-Power Medicine (NPM) has developed a systematic, unbiased pre-screening platform aimed at enhancing the efficiency and diversity of clinical trial enrollment. We provide results from a pilot study in prostate cancer in a single community oncology site. Methods: The NPM pre-screening platform consists of 3 components: (1) a patient registry (Kaleido); (2) onsite and remote staff to consent patients and ensure data completeness and standardization; and (3) technology to enable real-time data abstraction and workflow management. The platform reduces site burden and utilizes routine care data captured in electronic medical records (EMR) combined with the standardized abstraction of select clinical trial-relevant variables for prostate cancer patients. Data was abstracted prior to each visit in order to capture potential clinical trial candidates in a timely fashion. Results: 781 patients had a visit from March to December 2024. Median age was 75 years (range 46-98). 75% of patients were aged below 80. 31% were metastatic, 62% had early stage disease, 6.3% were completing staging studies or had unknown or missing status for stage/metastatic status. In patients with metastatic disease (249), the distribution of ECOG PS was (0/1/2/3/4): 46%/18%/14%/3%, and not available in 18% of patients. In the time interval, among pts with metastatic disease, 28 pts were identified when treatment-naive, 14 transitioning to 2nd line of therapy, 9 to 3rd line of therapy and 42 to 4th or later line of therapy. Conclusions: The NPM platform enabled systematic and unbiased pre-screening identifying patients at transition points of care when they are potential candidates for clinical trials in a timely fashion. The platform has the potential to improve the recruitment process without adding burdens to oncology sites as the process can be automated so as to select the subset of patients most likely to be trial eligible, thereby improving the efficiency of research and physician staff in final review of these selected patients for trial participation. This approach is a critical step toward enhancing trial execution efficiency and enabling greater participant diversity.