Prostate cancer screening with PSA and MRI followed by targeted biopsy only Journal Article


Authors: Hugosson, J.; Månsson, M.; Wallström, J.; Axcrona, U.; Carlsson, S. V.; Egevad, L.; Geterud, K.; Khatami, A.; Kohestani, K.; Pihl, C. G.; Socratous, A.; Stranne, J.; Godtman, R. A.; Hellström, M.; for the GÖTEBORG-2 Trial Investigators
Contributor: Lilja, H.
Article Title: Prostate cancer screening with PSA and MRI followed by targeted biopsy only
Abstract: BACKGROUND: Screening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown. METHODS: We invited 37,887 men who were 50 to 60 years of age to undergo regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter or higher underwent magnetic resonance imaging (MRI) of the prostate; one third of the participants were randomly assigned to a reference group that underwent systematic biopsy as well as targeted biopsy of suspicious lesions shown on MRI. The remaining participants were assigned to the experimental group and underwent MRI-targeted biopsy only. The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically significant prostate cancer, defined as a Gleason score of at least 3+4. Safety was also assessed. RESULTS: Of the men who were invited to undergo screening, 17,980 (47%) participated in the trial. A total of 66 of the 11,986 participants in the experimental group (0.6%) received a diagnosis of clinically insignificant prostate cancer, as compared with 72 of 5994 participants (1.2%) in the reference group, a difference of -0.7 percentage points (95% confidence interval [CI], -1.0 to -0.4; relative risk, 0.46; 95% CI, 0.33 to 0.64; P<0.001). The relative risk of clinically significant prostate cancer in the experimental group as compared with the reference group was 0.81 (95% CI, 0.60 to 1.1). Clinically significant cancer that was detected only by systematic biopsy was diagnosed in 10 participants in the reference group; all cases were of intermediate risk and involved mainly low-volume disease that was managed with active surveillance. Serious adverse events were rare (<0.1%) in the two groups. CONCLUSIONS: The avoidance of systematic biopsy in favor of MRI-directed targeted biopsy for screening and early detection in persons with elevated PSA levels reduced the risk of overdiagnosis by half at the cost of delaying detection of intermediate-risk tumors in a small proportion of patients. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN Registry number, ISRCTN94604465.). Copyright © 2022 Massachusetts Medical Society.
Keywords: controlled study; nuclear magnetic resonance imaging; magnetic resonance imaging; prostate specific antigen; randomized controlled trial; diagnostic imaging; prostate-specific antigen; prostatic neoplasms; prostate tumor; early detection of cancer; humans; human; male; early cancer diagnosis; social group
Journal Title: New England Journal of Medicine
Volume: 387
Issue: 23
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2022-12-08
Start Page: 2126
End Page: 2137
Language: English
DOI: 10.1056/NEJMoa2209454
PUBMED: 36477032
PROVIDER: scopus
PMCID: PMC9870590
DOI/URL:
Notes: Article -- The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF. -- Export Date: 3 January 2023 -- Source: Scopus
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  1. Hans Gosta Lilja
    345 Lilja
  2. Sigrid Viktoria Carlsson
    221 Carlsson