Current management of prostate cancer (PC) lacks biomarker tests and diagnostic procedures that can accurately distinguish clinically significant and clinically insignificant PCs at an early stage of the disease.
To compare the Stockholm 3 (STHLM3) test and prostate-specific antigen (PSA) as entry tests for magnetic resonance imaging (MRI) in a prospective study of PC diagnosis in general practice.
Participants were biopsy-naïve men aged 50-69 yr who had a PSA test in general practice. Participants with PSA 1-10 ng/ml also had an STHLM3 test and were referred for MRI if the STHLM311 test was positive (risk ≥11%) and/or PSA ≥3 ng/ml, and to targeted MRI-guided biopsy (MRGB) if their Prostate Imaging-Reporting and Data System (PI-RADS) score was ≥3.
The primary outcome was the number of International Society of Urological Pathology grade group ≥2 (GG ≥2) cases detected with a positive STHLM311 test versus PSA ≥3 ng/ml. Post hoc analysis was performed using a higher STHLM3 test cutoff (risk ≥15%; positive STHLM315 test).
Between January 2018 and December 2021, we recruited 1905 men. The STHLM3 test was performed in 1134 participants. Of these, 437 underwent MRI and 117 underwent MRGB, which detected 38 (32.5%) GG ≥2 and 52 (44.4%) with GG 1 cases. In comparison to PSA ≥3 ng/ml, a positive STHLM311 test increased detection of GG ≥2 from 30 to 37 cases (23.3%, 95% confidence interval [CI] 5.6-52.2%) and detection of GG 1 from 37 to 50 cases (35.1%, 95%CI 11.6-66.7%). STHLM315 positivity did not differ from PSA ≥3 ng/ml regarding detection of GG ≥2 PC (30 vs 32; 6.6%, 95% CI -8.1% to 25.9%), GG 1 PC (37 vs 37; 0.0%, 95% CI -19.6% to 25.0%), or MRGB use (88 vs 83; -5.7%, 95% CI -17.9% to 7.4%), but reduced MRI scans from 320 to 236 (-26.2%, 95% CI -33.1% to -18.9%).
The STHLM311 test improved sensitivity but not specificity for detection of GG ≥2 PC in the clinical setting of nonsystematic PC testing in general practice. Further studies are needed to validate a possible benefit of using a higher cutoff for STHLM3 positivity as an entry test for MRI.
We used a test called STHLM3 for detection of prostate cancer in general practice and compared its performance to the conventional PSA (prostate-specific antigen) test. We found that STHLM3 test results of 11% or above were not better at selecting men for MRI (magnetic resonance imaging) scans than the PSA test with a cutoff of 3 ng/ml or above. Analysis suggested that a higher cutoff for a positive STHLM3 test may improve selection of men for MRI scans, but further validation is needed.
European urology oncology. 2023 Aug 01 [Epub ahead of print]
Jacob Fredsøe, Mads Sandahl, Peter Vedsted, Jørgen Bjerggaard Jensen, Benedicte Parm Ulhøi, Michael Borre, Karina Dalsgaard Sørensen, Bodil Ginnerup Pedersen, PRIMA Study Group
Department of Molecular Medicine, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark., Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Radiology, Aarhus University Hospital, Aarhus N, Denmark., Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Research Unit for General Practice, Research Centre for Cancer Diagnosis in Primary Care, Aarhus C, Denmark., Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Urology, West Jutland Regional Hospital, Holstebro, Denmark., Department of Pathology, Aarhus University Hospital, Aarhus N, Denmark., Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark; Department of Urology, Aarhus University Hospital, Aarhus N, Denmark., Department of Molecular Medicine, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus N, Denmark. Electronic address: ., Department of Radiology, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: .