Validation in a Multiple Urology Practice Cohort of the Prostate Cancer Prevention Trial Calculator for Predicting Prostate Cancer Detection

Purpose: The Prostate Cancer Prevention Trial prostate cancer risk calculator was developed in a clinical trial cohort that does not represent men routinely referred for prostate biopsy. We assessed the generalizability of the Prostate Cancer Prevention Trial calculator in a cohort more representative of patients referred for consideration of prostate biopsy in American urology practice. Materials and Methods: Patients undergoing prostate biopsy by 12 urologists at 5 sites were enrolled in an Early Detection Research Network cohort. The Prostate Cancer Prevention Trial risk calculator was validated by examining area underneath the receiver operating characteristic curve, sensitivity, specificity and calibration comparing observed vs predicted risk of prostate cancer detection. Results: Cancer incidence was greater (43% vs 22%, p = 0.001) in the Early Detection Research Network validation cohort (645) compared to the Prostate Cancer Prevention Trial group (5,519). Early Detection Research Network participants were younger and more racially diverse, and had more abnormal digital rectal examinations and higher prostate specific antigen than Prostate Cancer Prevention Trial participants (all p < 0.001). Cancer severity was worse in the Early Detection Research Network cohort than in the Prostate Cancer Prevention Trial (Gleason 7 or higher 60% vs 21%, p < 0.001). Nevertheless, the Prostate Cancer Prevention Trial risk calculator was superior to prostate specific antigen alone for predicting cancer in the Early Detection Research Network (AUC 0.691 vs 0.655, p = 0.009) and calibration confirmed that the Prostate Cancer Prevention Trial risk score accurately predicted individual risks in the Early Detection Research Network cohort. Conclusions: Differences between the Early Detection Research Network validation cohort and the Prostate Cancer Prevention Trial cohort underscore the importance of validating calculator performance in the multicenter urology practice setting. Our findings extend the applicability of the Prostate Cancer Prevention Trial calculator for measuring the risk of prostate cancer detection on biopsy to the routine American urology practice setting.