Extending Current Guideline-recommended Prostate-specific Antigen Density Thresholds for Improving Benefit/Harm Balance in Risk-based Magnetic Resonance Imaging-directed Prostate Cancer Diagnosis, from the Community-based Multicentre MR-PROPER Study.
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Prinsen Anne M A, Wagensveld Ivo M, Osses Daniel F, Groenendijk Pieter M, Zijta Frank M, Busstra Martijn B, Rociu Elena, Barentsz Jelle O, Sedelaar J P Michiel, Arbeel Berber, Roeleveld Ton, Geenen Remy, Koeter Ingrid, van der Meer Saskia, Cappendijk Vincent C, Klaver Sjoerd, van der Lely Hans, Wolters Tineke, Leter Maicle R, van der Poel Henk G, Heijmink Stijn W T P J, Immerzeel Jos, Leijte Joost A P, van Roermund Joep G H, Miclea Razvan L, Planken Erik, Vis André N, de Jong Igle J, Tijsterman Jasper, Wolterbeek Derk, Claessen Anoesjka, Nederend Joost, Bangma Chris H, Roobol Monique J, Remmers Sebastiaan, van den Bergh Roderick C N, Somford Diederik M, Schoots Ivo G
Аннотация
METHODS: A post hoc analysis was conducted in the MRI arm of the prospective multicentre MR-PROPER study, originally comparing diagnostic outcomes with a risk calculator-based approach. PSA density thresholding strategies were investigated in PCa-suspected biopsy-naïve men undergoing MRI and targeted biopsy for Prostate Imaging Reporting and Data System (PI-RADS) score ≥3. Outcomes were grade group (GG) ≥2 cancer detection, avoided MRI scans, negative biopsies, and GG1 cancer detection, also addressed by benefit-to-harm ratios.
KEY FINDINGS AND LIMITATIONS: MR-PROPER included 996 PCa-suspected men in the MRI pathway (per-protocol analysis). The GG ≥2 cancer detection rate was 24% (239/996). False MR-positive results were obtained in 47% (217/456; 133 negative biopsies and 84 GG1 cancer cases). In PI-RADS 3 men, post-MRI PSA density thresholding at ≥0.20 ng/ml2 left 1.3% (0-2.7%; 3/239) GG≥2 cancer cases undetected, while avoiding 29% (22-35%; 38/133) negative biopsies and a 3.6% (0-8.2%; 3/84) GG1 cancer detection rate. To indicate MRI, pre-MRI PSA density thresholding at ≥0.10 ng/ml2 avoided 38% (31-44%; 50/133) unproductive biopsies, GG1 cancer detection in 12% (6.1-17%; 10/84), and 30% (27-33%; 301/996) MRI scans, incurring 9.6% (5.4-14%; 23/239) undetected GG ≥2 cancer cases.
CONCLUSIONS AND CLINICAL IMPLICATIONS: In a community-based diagnostic setting (24% GG ≥2 disease), applying a post-MRI PSA density threshold of ≥0.20 rather than the recommended threshold of 0.10 ng/ml2 in men with PI-RADS 3 lesions reduces unnecessary biopsies while maintaining oncological safety. This improved the benefit-to-harm ratio of risk-based PCa diagnostics, particularly in cancer-averse settings. For MRI indication, a pre-MRI PSA density threshold of ≥0.10 ng/ml2 supports a favourable benefit-to-harm ratio, though with narrow safety margins. These findings may inform risk-adapted strategies, particularly in biopsy-averse settings.