Introduction: The current literature indicates a superior prognostic performance of prostate MRI as compared to prostate-specific antigen (PSA) for prostate cancer (PCa) detection. This study evaluates the implementation of biparametric MRI (bpMRI) of the prostate as a PSA-independent screening tool for PCa. Following an interims analysis our study protocol was adjusted in order to reduce the detection of nonclinically relevant prostate cancer (< WHO/ISUP II). Methods: We included asymptomatic, biopsy-naïve patients older than 50 years into our study. All patients underwent 3 Tesla bpMRI of the prostate. In the presence of a suspicious lesion PI-RADS >3, only targeted biopsy was performed. After an interims analysis (n = 110) the study protocol was adjusted and PI-RADS 3 lesions were re-assessed through a 6 month follow-up MRI and only led to a biopsy if the lesion was persistent, growing or PI-RADS > 3. Template prostate biopsy in negative bpMRI was only performed if digital rectal examination (DRE) was suspicious or PSA exceeded 10 ng/ml. Results: In overall, 244 patients were included in the analysis. The median PSA was 1.33 ng/ml (IQR 0.75 – 2.88). In total, bpMRI detected suspicious PI-RADS lesions in 70 patients and biopsy was performed in 71 patients. We detected 6/26 (23.1 %) nonclinically relevant cancers (ISUP I) and 20/26 (76.9 %) clinically relevant cancers (ISUP = II). All (20 / 20) of the clinically relevant cancers were detected by bpMRI while 50 % (10 / 20) would have been missed by PSA and digital rectal examination. Conclusions: Screening with bpMRI has the potential to detect prostate cancer otherwise missed by classical screening methods at a remarkably low PSA. This comes at the cost of the detection of nonclinically relevant PCa in 23.1 % of the patients and negative biopsies in 63.4 % of the patients. While this reflects probably a high sensitivity for the detection of clinically relevant PCa, the protocol may be refined using companion tests, like Stockholm 3 (SH3) in order to reduce imaging procedures and biopsies. SOURCE OF Funding: The study is funded by the Departments of Urology and Radiology at University Hospital Basel, Switzerland.
