Dias, Adriano Basso

AbstractObjectiveTo evaluate the diagnostic performance of multiparametric MRI (mpMRI), mpMRI combined with PSA density (PSAd) and combined biopsy (CBx) in detecting clinically significant prostate cancer (csPCa) in men undergoing active surveillance, using radical prostatectomy (RP) specimens as the reference standard.Patients and MethodsIn this prospective single‐centre study, 91 patients with low‐risk prostate cancer under active surveillance underwent mpMRI, PSAd measurement, CBx and ultimately RP. mpMRI was reported using PI‐RADS v2.0, and PSAd was dichotomised at 0.12 ng/ml/cm3. Diagnostic accuracy was compared using ISUP grade ≥2 and ≥3 thresholds. Radical prostatectomy pathology served as the reference standard.ResultsFor detecting ISUP ≥3 cancer, mpMRI combined with PSAd achieved the highest sensitivity (93.3%) and negative predictive value (94.4%). CBx demonstrated the highest specificity (88.2%) and overall diagnostic balance (Youden index = 0.348). mpMRI alone showed intermediate performance. Differences in classification between strategies were statistically significant (McNemar p < 0.001).ConclusionsmpMRI combined with PSAd provides high sensitivity and negative predictive value for ruling out aggressive prostate cancer, supporting its use as a non‐invasive triage tool in active surveillance. CBx remains the most specific method for histological confirmation. These strategies should be used complementarily to optimise decision‐making in active surveillance protocols.

Importance Multiparametric magnetic resonance imaging (MRI), with or without prostate biopsy, has become the standard of care for diagnosing clinically significant prostate cancer. Resource capacity limits widespread adoption. Biparametric MRI, which omits the gadolinium contrast sequence, is a shorter and cheaper alternative offering time-saving capacity gains for health systems globally. Objective To assess whether biparametric MRI is noninferior to multiparametric MRI for diagnosis of clinically significant prostate cancer. Design, Setting, and Participants A prospective, multicenter, within-patient, noninferiority trial of biopsy-naive men from 22 centers (12 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] level and/or abnormal digital rectal examination findings) from April 2022 to September 2023, with the last follow-up conducted on December 3, 2024. Interventions Participants underwent multiparametric MRI, comprising T2-weighted, diffusion-weighted, and dynamic contrast–enhanced (DCE) sequences. Radiologists reported abbreviated biparametric MRI first (T2-weighted and diffusion-weighted), blinded to the DCE sequence. After unblinding, radiologists reported the full multiparametric MRI. Patients underwent a targeted biopsy with or without systematic biopsy if either biparametric MRI or multiparametric MRI was suggestive of clinically significant prostate cancer. Main outcomes and measures The primary outcome was the proportion of men with clinically significant prostate cancer. Secondary outcomes included the proportion of men with clinically insignificant cancer. The noninferiority margin was 5%. Results Of 555 men recruited, 490 were included for primary outcome analysis. Median age was 65 (IQR, 59-70) years and median PSA level was 5.6 (IQR, 4.4-8.0) ng/mL. The proportion of patients with abnormal digital rectal examination findings was 12.7%. Biparametric MRI was noninferior to multiparametric MRI, detecting clinically significant prostate cancer in 143 of 490 men (29.2%), compared with 145 of 490 men (29.6%) (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points; P = .50). Biparametric MRI detected clinically insignificant cancer in 45 of 490 men (9.2%), compared with 47 of 490 men (9.6%) with the use of multiparametric MRI (difference, −0.4 [95% CI, −1.2 to 0.4] percentage points). Central quality control demonstrated that 99% of scans were of adequate diagnostic quality. Conclusion and relevance In men with suspected prostate cancer, provided image quality is adequate, an abbreviated biparametric MRI scan, with or without targeted biopsy, could become the new standard of care for prostate cancer diagnosis. With approximately 4 million prostate MRIs performed globally annually, adopting biparametric MRI could substantially increase scanner throughput and reduce costs worldwide. Trial registration ClinicalTrials.gov Identifier: NCT04571840