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Randomized Controlled Trial
. 2024 Feb 5;7(2):e2354577.
doi: 10.1001/jamanetworkopen.2023.54577.

Repeated Prostate Cancer Screening Using Prostate-Specific Antigen Testing and Magnetic Resonance Imaging: A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial

Tobias Nordström  1   2 , Magnus Annerstedt  3 , Axel Glaessgen  4 , Stefan Carlsson  5   6 , Mark Clements  1 , Ahmad Abbadi  1 , Henrik Grönberg  1 , Fredrik Jäderling  6   7 , Martin Eklund  1 , Andrea Discacciati  1
Affiliations
Randomized Controlled Trial

Repeated Prostate Cancer Screening Using Prostate-Specific Antigen Testing and Magnetic Resonance Imaging: A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial

Tobias Nordström et al. JAMA Netw Open. .

Abstract

Importance: Magnetic resonance imaging (MRI) has been proposed to enhance the benefit-to-harm ratio of prostate cancer screening, but data on repeated screening outcomes are lacking.

Objective: To describe outcomes of prostate-specific antigen (PSA)-based screening with MRI and prostate biopsies at repeat screening.

Design, setting, and participants: This secondary analysis examined the population-based, screen-by-invitation STHLM3-MRI randomized clinical trial, which recruited Swedish men aged 50 to 74 years. Men were eligible for repeat screening at 2 to 3 years if they had PSA levels of 1.5 ng/mL or greater at trial inclusion, were randomized to the MRI-targeted group (including screening using biomarkers and MRI), and were not diagnosed with prostate cancer after the first screening round. Repeat screening was performed between November 10, 2021, and February 20, 2023. Data analysis was performed between May and August 2023.

Intervention: Participants underwent blood sampling, including PSA testing. A biparametric MRI scan was performed if PSA levels were 3 ng/mL or greater, and men with lesions with a Prostate Imaging-Reporting and Data System (PI-RADS) score of 3 or greater were referred for targeted and systematic biopsies.

Main outcomes and measures: The primary outcome was clinically significant prostate cancer (Gleason score of ≥3 + 4). Secondary outcomes included the proportion of men with clinically insignificant cancer (Gleason score of 6), the number of elevated PSA tests, MRI scans, and biopsy procedures.

Results: Of 7609 men from the first screening round, 2078 (27.3%) were eligible for and were invited for rescreening. Among the invitees, 1500 (72.2%) participated. Their median age was 67 (IQR, 61-72) years. Of 1094 men with PSA levels between 1.5 and 2.9 ng/mL in the first screening round, 326 (29.8%) had levels of 3 ng/mL or greater in the second round. Overall, 667 men (44.5%) had PSA levels of 3 ng/mL or greater: 617 underwent MRI (92.5%), revealing 51 (7.6%) with equivocal lesions (PI-RADS score of 3) and 33 (4.9%) with suspicious lesions (PI-RADS score of ≥4). Only 10 of 383 men (2.6%) with a prior negative MRI result had a lesion with a PI-RADS score of 4 or greater. Among the 1500 rescreened men, 48 (3.2%) had a Gleason score of 3 + 4 or greater, including 19 (1.3%) with a score of 4 + 3 or greater and 11 (0.7%) with a score of 6.

Conclusions and relevance: In this secondary analysis of the STHLM3-MRI randomized clinical trial, cancer detection during the second screening round in biennial PSA and MRI-based prostate cancer screening was limited, and the detection of low-grade tumors remained low. A substantial proportion of men exhibited elevated PSA levels during rescreening, and a considerable portion of MRI scans performed lacked lesions suggestive of cancer. Future studies should explore strategies to reduce MRI-related resource use.

Trial registration: ClinicalTrials.gov Identifier: NCT03377881.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Nordström reported receiving grants from the Swedish Cancer Society (Cancerfonden), the Swedish Research Council (Vetenskapsrådet), and Prostatacancerförbundet during the conduct of the study. Dr Clements reported receiving grants from Vetenskapsrådet, the Swedish Prostate Cancer Foundation, Cancerfonden, the Karolinska Institutet, and the European Union during the conduct of the study. Prof Grönberg reported receiving grants from Janssen and AstraZeneca outside the submitted work. In addition, Prof Grönberg reported holding 1 patent for prostate cancer diagnostics licensed to A3P Biomedical AB, which collaborates with the Karolinska Institutet in developing the technology for the Stockholm3 test, and has 5 patents pending for prostate cancer diagnostics. Prof Eklund reported receiving grants from Vetenskapsrådet, Cancerfonden, and the Swedish Prostate Cancer Society during the conduct of the study and holding stock in A3P Biomedical AB outside the submitted work. In addition, Prof Eklund reported holding patents for a refined prostate cancer risk assessment for low-risk cases, for a method to indicate a presence of aggressive prostate cancer, and for a prognostic method that estimates the need for prostate cancer therapy, all licensed to A3P Biomedical AB. No other disclosures were reported.

Figures

Figure.
Figure.. Profile of the Population-Based, Screen-by-Invitation STHLM3-MRI Randomized Clinical Trial
MRI indicates magnetic resonance imaging; PI-RADS, Prostate Imaging–Reporting and Data System; and PSA, prostate-specific antigen.
See this image and copyright information in PMC

Comment in

References

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