A pre-specified sub-analysis of the randomised Gothenburg-2 screening trial followed 1,685 men whose initial MRI was negative (PI-RADS 2 or below) for a median of 5.5 years. Cumulative incidence of clinically significant cancer at seven years was 7.1% overall, and 5.5%, 13.8% and 11.9% across ascending PSA density bands; 42 of the 80 significant cancers nonetheless arose in the lowest-density group, 12 of them high-grade (Gleason 4+3 or above). A modelled PSA-density-triggered follow-up reduced MRI use by 60% and biopsies by 46% while delaying diagnosis in 17% of significant cases.
Why it is interesting: Quantifies how much residual cancer risk remains after a negative screening MRI, and the detection traded away by triaging repeat imaging on PSA density.