Balancing harm minimization and oncological safety in MRI-informed prostate cancer screening - 12/11/26

Doi : 10.1016/j.diii.2026.11.001

Charlie Alexander Hamm ^a,^b,^⁎ , Salina Alaro ^a, Leila Vivien Nitschke ^a, Anwar R. Padhani ^c, Karsten Günzel ^d, Maximilian Lindholz ^a,^b, Johannes Kolck ^a, Carsten Stephan ^e, Moritz Wagner ^a, Thula Walter-Rittel ^a, Dominik Geisel ^a, Tobias Penzkofer ^a,^b, Jens Vogel-Claussen ^a, Bernd Hamm ^a, Patrick Asbach ^a,^{^{1
These authors contributed equally}}, Federico Collettini ^a,^{^{1
These authors contributed equally}}

^a Department of Radiology, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany

^b Berlin Institute of Health, Anna-Louisa-Karsch-Straße 2, 10178 Berlin, Germany

^c Paul Strickland Scanner Centre, Mount Vernon Cancer Centre, Northwood HA6 2RN, United Kingdom

^d Department of Urology, Vivantes Klinikum Am Urban, 10967 Berlin, Germany

^e Department of Urology, Charité Universitätsmedizin Berlin, 10117 Berlin, Germany

^⁎ Corresponding author at: Department of Radiology, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany. Department of Radiology Charité Universitätsmedizin Berlin Berlin 13353 Germany

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Thursday 12 November 2026

Highlights

•	MRI-first screening detected 94% of significant prostate cancers in men between the ages of 50 and 69.
•	Prostate-specific antigen testing alone would have missed 39–50% of significant prostate cancers.
•	MRI-informed strategies outperformed prostate-specific antigen testing alone in all measures.
•	A prostate-specific antigen-gated MRI strategy would have spared 89% of men from unnecessary biopsy.

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Abstract

Purpose

Risk-adapted prostate cancer screening is endorsed by international healthcare organizations. However, oncological safety and harm minimization in magnetic resonance imaging (MRI)–informed screening lack validation. The purpose of this study was to evaluate the diagnostic utility of an MRI-first screening strategy for detecting grade group (GG) ≥ 2 prostate cancer.

Materials and methods

This prospective, multi-site study recruited men between the ages of 50 and 69 from three public service providers in Berlin. Eligible participants underwent MRI and serum prostate-specific antigen (PSA) testing at two imaging centers. Prostate biopsy was recommended following MRI positivity (score 4–5) or serum PSA ≥ 4 ng/mL (high-risk). MRI-negative men (score 1–2) with PSA < 3 ng/mL were discharged (low-risk), while men with an MRI score of 3 or a PSA of 3–4 ng/mL were actively followed and invited to repeat screening after 1 year (indeterminate-risk). The primary outcome was the proportion of risk groups and GG ≥ 2 prostate cancer detected using MRI alone or combined with PSA.

Results

Of 587 screened men, 566 (mean age, 57.2 ± 4.7 years [SD]; range: 50–69 years) were eligible, and 552 underwent both screening tests. Of these, 78/552 (14.1%; 95% CI: 11.5–17.3), 51/552 (9.2%; 95% CI: 7.1–11.9), and 423/552 (76.6%; 95% CI: 72.9–80.0) were classified as high-, indeterminate-, and low-risk, respectively. PSA testing alone would have missed 9/18 (50.0%) and 7/18 (38.9%) of screen-detected GG ≥ 2 prostate cancers at ≥ 4 and ≥ 3 ng/mL thresholds. Biopsying MRI-positive men detected 17/18 (94.4%) of GG ≥ 2 prostate cancers. A PSA-gated (≥ 3 ng/mL) MRI-informed strategy demonstrated excellent strategy compliance (13/13 [100.0%]), could protect 24/27 (88.9%) from unproductive biopsies and GG1 overdiagnosis, and detect 10/18 (55.6%) of GG ≥ 2 prostate cancers.

Conclusion

MRI-first screening demonstrates high oncological safety for GG ≥ 2 prostate cancer but increases overdiagnosis and biopsy rates. PSA-gated MRI-informed strategies may reduce harm while maintaining acceptable detection rates.

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Keywords : Magnetic resonance imaging, Prostate cancer, Prostate-specific antigen, Screening

Abbreviations : CI, CHU, csPCa, DCA, FN, GG, GGx, H, ISUP, MRI, NA, NNB, NNS, PB, PCa, PI-RADS, PSA, Pt, SD, STROBE, Q1, Q3