864 Does the PROMIS Trial Deliver What It Promised? Validation in a North West Population

Abstract

Abstract Aim The PROMIS trial changed the landscape on how men with raised PSA are evaluated. We changed the pathway at a North West hospital, utilising multiparametric MRI (MP-MRI) scans and incorporated additional safety parameters (family history and PSA density) to maintain the advantage of avoiding unnecessary biopsy whilst not missing significant cancers. We present the performance of this pathway. Method We retrospectively reviewed 596 referrals of men with high PSA level between January - December 2021. Variables audited included demographics, PSA level, PSA density, Prostate Imaging-Reporting and Data System (PI-RADS) score on MP-MRI, biopsy results, Gleason score and prognostic grade grouping. Results Of 596 patients, 65.9% of men were aged between 50-75 years. The most common quintile of presenting PSA was 4.00-9.99 (53.2%). Of the 381 patients with non-metastatic prostate cancer who underwent MP-MRI, 38.3% were classed as PI-RAD 1-2, 16% PI-RAD 3 and 45.7% PI-RAD 4-5. Overall, 48.3% of patients did not undergo biopsy. Biopsy rates in PI-RAD 1-5 were 2.3%, 3.9%, 52.5%, 92.5% and 91.5% respectively, the decision made to monitor PSA instead in some cases due to co-morbidities or patient preference. Of 197 biopsies, 79.2% were positive, 87.8% initially classed as PI-RADS 4 or 5. Of the cancers picked up, 82.1% were clinically significant (Gleason score ≥3+4). Conclusions This study shows the pathway incorporating MP-MRI, family history and PSA density enables 48.3% of patients to avoid unnecessary biopsy and therefore overdiagnosis of clinically insignificant cancers. The PROMIS trial delivers what it promised.