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© Translational Andrology and Urology. All rights reserved. A recent commentary by Choyke and Bouchelouche (1) highlighted a number of important points relevant to the origins and history of small-molecule inhibitors of prostate-specific membrane antigen (PSMA) and their use as imaging agents for positron emission tomography (PET). As the authors note, there has been rapid adoption of PSMA-targeted PET throughout much of the world (1), with hundreds of publications being generated each year (2). The facile incorporation of PSMA-targeted PET into clinical practice belies the tremendous amount of time and effort spent on medicinal chemistry to develop this new class of radiotracers, as well as the preclinical evaluations that were necessary to validate PSMA as a viable target for imaging prostate cancer (3,4). Furthermore, as Choyke and Bouchelouche note in their manuscript, much of the early literature with PSMA-targeted PET was retrospective and/ or anecdotal (1), effectively putting the cart before the horse in regards to clinical validation (5), and potentially limiting future prospects for rigorous, randomized trials in some clinical applications (1). Nonetheless, exciting developments continue to come to the forefront with PSMA, and there is every reason to believe that we have only scratched the surface. For example, prospective, multi-center studies in the United States (6) and ClinicalTrials.gov (NCT02981368 and NCT03739684) have positioned PSMA-targeted PET for regulatory approval in that jurisdiction in the near future. Such approval may be the impetus needed to continue the types of large, collaborative studies that will definitively elucidate the clinical utility of this new imaging technique in clinical scenarios such as pre-operative staging and biochemical recurrence. Beyond the sensitivity and specificity data from such studies, the more subtle prognostic information associated with scan findings should be sought. There are already indications that PSMA-targeted PET scans contain imaging biomarkers that are not accounted for simply by the detection efficiency of the scan (7), and this observation will need to be more thoroughly understood by leveraging the larger datasets that will continue to become available. Dovetailing with the emerging data from multi-center studies is the worldwide experience that has led to an understanding of potential false-positive and false-negative findings as well as the appearances of numerous nonprostate cancer entities on PSMA-targeted PET. Indeed, the pitfalls that can lead to inaccurate staging of patients who are imaged with PSMA-targeted PET have been extensively described (8). This, in turn, has allowed for the development of standardized reporting systems [for example, (9)] that can reflect the inherent uncertainty that arises with normal variants, lesions with indeterminate levels of uptake, and other confusing imaging patterns. In our clinical practice, we make use of the PSMA reporting and data system (PSMA-RADS), which is structured as a 5-point scale based on the likelihood of the presence of Letter to the Editor

Prostate-specific membrane antigen (PSMA) imaging: the past is prologue and the future is scintillating