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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