The role of PSA density in the follow up of men with a negative MRI in the Göteborg-2 trial.

Authors

Fredrik Möller, Marianne Månsson, Mikael Hellström, Fredrik Langkilde, Vasiliki Spyratou, Johan Stranne, Jonas Wallström, Jonas Hugosson, Rebecka Arnsrud Godtman

Published in

BJU international. Sep 18, 2026. Epub Sep 18, 2026.

Abstract

To assess whether prostate-specific antigen density (PSAD) stratifies long-term risk of clinically significant prostate cancer (csPCa) after a negative magnetic resonance imaging (MRI; Prostate Imaging-Reporting and Data System score ≤2) and to evaluate the potential of PSAD to guide follow-up in a screening setting.
This pre-specified sub-analysis of the population-based, randomised Göteborg-2 screening trial included 1685 men who underwent PSA testing between October 2015 and June 2021 and had a subsequent negative initial MRI. Follow-up continued until 30 September 2024. The primary endpoint was cumulative incidence of csPCa (Gleason score ≥3 + 4). Men were categorised by baseline PSAD (<0.10, 0.10 to <0.15, and ≥0.15 ng/mL²). Cumulative incidence was estimated using Kaplan-Meier methods and compared using the log-rank test. The clinical implications of PSAD-based follow-up strategies were explored.
Over a median follow-up of 5.5 years, 160 PCas were diagnosed, of which 80 were csPCa, including 22 cases of Gleason score ≥4 + 3. At 7 years, cumulative csPCa incidence was 7.1% overall and 5.5%, 13.8%, and 11.9% in the PSAD <0.10, 0.10 to <0.15, and ≥0.15 ng/mL² groups, respectively (P < 0.001 for PSAD <0.10 ng/mL² vs both higher groups). Overall, 87% of repeat MRIs remained negative. Although men with baseline PSAD <0.10 ng/mL² had the lowest overall risk, 42 csPCas occurred in this group, including 12 Gleason score ≥4 + 3, emphasising the importance of continued regular PSA-based follow-up. A PSAD-guided strategy with biennial PSA testing and repeat MRI triggered by PSAD ≥0.10 ng/mL² could reduce MRI use by 60% and biopsies by 46%, halve detection of clinically insignificant PCa, and delay csPCa diagnosis in 17% of cases including 10 men with Gleason score 3 + 4 and one with Gleason score ≥4 + 3.
The PSAD stratifies long-term risk of csPCa after a negative MRI and supports risk-adapted follow-up in PCa screening.

PMID:
42759951
Bibliographic data and abstract were imported from PubMed on 19 Sep 2026.

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