Current diagnostic approaches cannot determine which patients with early prostate cancer are most at risk for progression or recurrence, which leaves patients and physicians in the difficult position of choosing between active surveillance or aggressive therapy based on population risks associated with subjectively assigned Gleason scores. Stratifying patients into high-risk and low-risk groups at the time of initial biopsy or prostatectomy would provide critical information that providers and patients need to make decisions about prostate-sparing approaches or more aggressive treatment options that could improve patient outcomes. In this Phase I contract, Reveal Biosciences proposes to advance the development of imageDx: Prostate, an image-based, artificial-intelligence (AI)-enabled prognostic test designed to stratify patients with early stage prostate cancer according to their risk for disease progression or recurrence. Objectives include 1) selecting an imaging platform for test validation, 2) refining a user interface for the tool, 3) conducting a pilot study to demonstrate the feasibility of a risk prediction algorithm, 4) developing standard operating procedures for the tool, and 5) developing a regulatory strategy for test approval by the FDA.
