Prostate Biopsies Can Be Omitted in Most Patients with a Positive Stockholm3 Test and Negative Prostate Magnetic Resonance Imaging

Abstract

Background Magnetic resonance imaging (MRI) combined with the Stockholm3 test can be used to inform biopsy decision-making in patients with a suspicion of prostate cancer. Objective To determine the consequence of omitting biopsies in men with a positive Stockholm3 test and a negative MRI. Design, setting, and participants In a real-life setting, 438 men with a positive Stockholm3 test and a negative MRI underwent systematic biopsies from 2017 to 2020. Outcome measurements and statistical analysis The Stockholm3 test result is a percentage risk score with or without a prostate volume cutoff. The main outcomes were the number of clinically significant (Gleason grade group [GG] ≥2) and nonsignificant (GG 1) prostate cancers. Results and limitations Median prostate-specific antigen was 4.5 ng/ml (interquartile range 2.8–6.4 ng/ml) and the median age was 69 yr. Systematic biopsies detected grade group (GG) ≥2 disease in 48 men (11%, 95% confidence interval [CI] 8.4–14.2%) and GG 1 disease in 94 men (21.5%, 95% CI 17.9–25.6%). Of 256 patients without a volume cutoff in the test report, GG ≥2 was detected in 37 men (14.5%, 95% CI 10.7–19.3%). Omitting biopsies in patients with a volume cutoff would miss 11 GG ≥2 cases (6%, 95% CI 3.4–10.5%), reduce the number of GG 1 cases detected by 37 (39.4%, 95% CI 30.1–49.5%), and avoid a total of 182 biopsies (41.6%, 95% CI 37.0–46.2%). Limitations include the lack of follow-up data. Conclusions Systematic biopsies can be omitted in patients with a positive Stockholm3 test and a negative MRI when there is a volume cutoff in the test report. With no volume cutoff, biopsies can be considered with shared decision-making.