Outcome of 5-year follow-up in men with negative findings on initial biparametric MRI

BACKGROUND: We assessed the 5-year risk of being diagnosed with significant prostate cancer following a low-suspicion biparametric magnetic resonance imaging result. METHODS: The study population was derived from a prospective database used to assess the diagnostic accuracy of biparametric magnetic resonance imaging for significant prostate cancer detection in 1020 biopsy-naïve men. Significant prostate cancer was defined as any core with Gleason grade group ≥3 or a maximum cancerous core length greater than 50% of Gleason grade group 2. A secondary definition of significant prostate cancer was also included: any core with prostate cancer Gleason grade group ≥2. Of the 1020 men, 305 had a low-suspicion biparametric magnetic resonance imaging result (Prostate Imaging Reporting and Data System score of 1 or 2) but four men were excluded from follow-up. Thus, the final study population consisted of 301 men, who were clinically followed-up from inclusion (November 2015 to June 2017) until 1 June 2021. FINDINGS: Overall, 1·7% (5/301) of the study population had significant prostate cancer diagnosed within 5 years (median 1480 days, Interquartile Range (1587–1382)) of their low-suspicion result and corresponding set of biopsies. When the secondary definition of significant prostate cancer was applied, this increased to 5% (15/301) of the study population. INTERPRETATION: The 5-year risk of being diagnosed with significant prostate cancer after a prebiopsy low-suspicion prebiopsy biparametric magnetic resonance imaging result was 1·7%.