Purpose
To determine rate of upgrading to Gleason score (GS) ≥ 4+3, using targeted biopsy for diagnosis and monitoring, in men undergoing active surveillance (AS) of prostate cancer (CaP).
Materials and Methods
Subjects were all 259 men (196 with GS 3+3 and 63 with GS 3+4) who were diagnosed by MRI/US fusion-guided biopsy (2009–2015) and who underwent subsequent fusion biopsy for as long as 4 years of AS. Primary endpoint was discovery of GS ≥ 4+3 CaP. Follow-up biopsies included targeting of positive sites, which were tracked in an Artemis device. Kaplan-Meier curves were generated to determine rates of upgrading, stratified by initial GS and PSA density.
Results
Based on a Cox proportional hazard model, men with GS 3+4 were 4.65 more likely to have upgrading than men with initial GS 3+3 (3yr, p < 0.01). 63% of men with GS 3+4 had upgraded by the third surveillance year, compared with 18.0% of men starting with GS 3+3 (p < 0.01). 97% of all upgrades (32/33) occurred within an MRI-visible or a tracked site of tumor, rather than a previously-negative systematic site. Independent predictors of upgrading were GS 3+4, PSA density ≥ 0.15 ng/ml/cm3, and a grade 5 lesion on MRI. The incidence-rate ratio of upgrading (GS 3+4 vs. GS 3+3) was 4.25 per year of patient follow-up (p < 0.01).
Conclusions
During AS of CaP, targeting of tracked tumor foci by MRI/US fusion biopsy allows heightened detection of GS ≥ 4+3 cancers. Baseline variables directly related to important upgrading and warranting increased vigilance include GS 3+4, PSA density ≥ 0.15, and grade 5 lesions on MRI.