PSA density stratified the long-term risk after a negative prostate MRI in the Göteborg-2 trial

Design

Pre-specified sub-analysis of the population-based randomised Göteborg-2 screening trial

Population

1,685 men with PSA testing and a negative initial MRI (PI-RADS 2 or lower)

Primary outcome

Cumulative incidence of clinically significant prostate cancer (Gleason 3+4 or higher) by PSA density

Effect

7-year incidence 5.5% (PSAD under 0.10), 13.8% (0.10 to under 0.15), 11.9% (0.15 or more); 7.1% overall

This pre-specified sub-analysis of the Göteborg-2 screening trial included 1,685 men with a negative first MRI (PI-RADS 2 or lower) after PSA testing. Follow-up ran to September 2024, a median of 5.5 years.

During follow-up, 160 prostate cancers were found, 80 clinically significant (Gleason 3+4 or higher). Seven-year cumulative incidence of clinically significant cancer was 7.1% overall, and 5.5%, 13.8% and 11.9% for PSA density below 0.10, 0.10 to below 0.15 and 0.15 ng/mL² or higher. Repeat MRIs stayed negative in 87%. Even in the lowest band, 42 significant cancers occurred.

A strategy of repeat MRI only when PSA density reached 0.10 could cut MRI use by 60% and biopsies by 46% and halve detection of insignificant cancer, but would delay diagnosis of significant cancer in 17%. It is a modelled scenario, not a trial result.

• Calculate PSA density in men with a negative MRI.
• Do not discharge men from PSA follow-up on a low density; significant cancers still occurred.
• Consider earlier repeat MRI when PSA density is 0.10 ng/mL² or more.
• Discuss that a risk-adapted strategy trades fewer scans against some delayed diagnoses.
• Interpret in light of local MRI quality, since reader expertise affects negative predictive value.

Why it matters

A negative MRI is not the end of risk, and density helps choose who needs another look.

Don't overread it

A pre-specified sub-analysis in a Swedish screening population with high-quality MRI; it may not transfer to settings with different MRI access or reader experience.

The statistics, in plain English

Cumulative incidence of 5.5% at seven years means roughly one in eighteen men in the lowest band developed a significant cancer. The scenario figures, such as a 60% reduction in MRI use, come from modelling and do not include the harms of missed cancers beyond the delay counts given.

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