Prostate-specific antigen (PSA)-based screening for prostate cancer (PCa) has limited accuracy, and it is linked to overdiagnosis. The PROSA trial aimed to evaluate whether a contrast-free biparametric magnetic resonance imaging (bpMRI)-first screening strategy improves the detection of clinically significant PCa (csPCa) as the primary outcome.
The secondary outcomes included overall PCa detection, benefit-harm metrics, and cost effectiveness from a health care payer perspective.
This single-center, randomized controlled trial enrolled 816 asymptomatic men aged 49-69 yr (≥40 yr with a PCa family history). Participants were randomized into two arms: arm A underwent bpMRI regardless of the PSA levels; arm B received bpMRI only if PSA ≥3 ng/ml (or 2.5 ng/ml with a family history). Men with Prostate Imaging Reporting and Data System score ≥3 were directed to a targeted biopsy. Imaging and pathology assessors were blinded; csPCa is defined as International Society of Urological Pathology grade group ≥2. The primary outcomes included csPCa detection, benefit-harm metrics, and cost effectiveness from a health care payer perspective.
Among 759 randomized men, biopsy and csPCa detection rates were higher in arm A (10.8% and 4.6%, respectively) than in arm B (5.2% and 1.8%, respectively), with a relative risk of 2.6 (95% confidence interval 1.1-6.1; p = 0.05) for the csPCa detection rate. Benefit-harm metrics favored the MRI-first strategy, showing higher grade selectivity (1.89 vs 1.75), biopsy efficiency (0.74 vs 0.54), and biopsy avoidance (23.1 vs 11.9). No serious adverse event was recorded. The MRI-first strategy yielded an incremental cost-effectiveness ratio of €2201.75 per csPCa case detected. Limitations include single-round design and short follow-up.
In this randomized screening trial, a contrast-free MRI-first pathway improved csPCa detection, enhanced benefit-harm metrics, and showed favorable cost effectiveness.
European urology. 2025 Dec 17 [Epub ahead of print]
Emanuele Messina, Antonella Borrelli, Alessandro Sciarra, Ludovica Laschena, Debora Antonini, David Shaholli, Fabio M Magliocca, Simone Novelli, Daniele Santini, Giuseppe La Torre, Valeria Panebianco
Department of Radiological Sciences, Oncology and Pathology, Policlinico Umberto I, Sapienza University, Rome, Italy., Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I, Sapienza University, Rome, Italy., Department of Public Health and Infectious Diseases, Policlinico Umberto I, Sapienza University, Rome, Italy., Department of Mechanical and Aerospace Engineering, Sapienza University, Rome, Italy; Institute for Liver and Digestive Health, Royal Free Campus, University College London, London, UK., Medical Oncology Unit, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy., Department of Radiological Sciences, Oncology and Pathology, Policlinico Umberto I, Sapienza University, Rome, Italy. Electronic address: .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41412906