Stockholm3–Magnetic Resonance Imaging Population-Based Prostate Cancer Screening Study: Two-Year Follow-up
Menée en Suède à partir de données du registre national des cancers et de données portant sur 12 670 hommes inclus dans un programme de dépistage du cancer de la prostate (niveau sérique du PSA : supérieur ou égal à 3 ng/ml ; test Stockholm3 supérieur ou égal à 11 ; durée de suivi : 2 ans), cette étude examine la performance du test Stockholm3 (niveau du PSA + biomarqueurs plasmatiques + risque polygénique + facteurs cliniques) et de l'IRM couplée à des biopsies ciblées pour réduire le nombre de biopsies inutiles et le surdiagnostic
Background : Prostate-specific antigen (PSA) testing to screen for prostate cancer is controversial. An alternative approach, Stockholm3, combines PSA, plasma protein biomarkers, polygenic risk, and clinical factors into a multivariable risk score.
Objective : To compare detection of clinically significant prostate cancer (csPC) using PSA and Stockholm3 in a population-based screening with short-term follow-up.
Design : Secondary analysis of the baseline round of the prospective STHLM3-MRI (Prostate Cancer Screening Using a Combination of Risk-Prediction, MRI, and Targeted Prostate Biopsies) randomized screening trial in men aged 50 to 74 years who had PSA and
Stockholm3 screening. Men with abnormal screening tests (PSA ≥3 ng/mL or Stockholm3 ≥11) were randomly assigned (2:3) to systematic biopsy or magnetic resonance imaging with systematic and targeted biopsies for lesions with a Prostate Imaging Reporting and Data System score of 3 or greater. Cancer diagnosed within 2 years was identified through linkage to the Swedish National Cancer Register; cancer after a negative baseline test was classified as false negative. (ClinicalTrials.gov: NCT03377881)
Setting : Stockholm region, Sweden, 2018 to 2020.
Participants : Men aged 50 to 74 years who had PSA and Stockholm3 screening.
Intervention : Prostate-specific antigen and Stockholm3 tests at baseline.
Measurements : Clinically significant prostate cancer (grade group ≥2) within 2 years of baseline.
Results : Among 12 670 men, 443 (3.5%) were diagnosed with csPC. Decision curve analysis showed higher net benefit for Stockholm3 versus PSA across a range of decision thresholds for biopsy, indicating fewer unnecessary biopsies and fewer missed csPC cases. Stockholm3 (≥11) had a false-negative rate of 10% (43 of 443) and a false-positive rate of 11% (1289 of 12 227), whereas PSA (≥3 ng/mL) had a false-negative rate of 26% (116 of 443) and a false-positive rate of 10% (1203 of 12 227). Correspondingly, sensitivity was 90% (95% CI, 87% to 93%) for Stockholm3 and 74% (CI, 69% to 78%) for PSA, with similar specificity (89% vs. 90%).
Limitations : Participation was approximately 25% of invited men; follow-up was limited to 2 years; and the cohort was predominantly Swedish or European, which may limit generalizability.
Conclusion : In this screening cohort with short-term follow-up, Stockholm3 provided greater clinical net benefit than PSA for detecting csPC, driven by fewer false-negative results, although follow-up was limited to 2 years.
Primary Funding Source : Swedish Research Council, Swedish Prostate Cancer Society, Stockholm Region, and the Swedish Cancer Society.
Annals of Internal Medicine , résumé, 2026