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This study investigated whether prostate cancer screening using PSA levels and MRI followed by MRI-targeted biopsy (experimental group; n = 11,986) results in a lower rate of overdiagnosis compared with performing a systematic biopsy of suspicious lesions regardless of MRI results along with targeted biopsy if MRI revealed suspicious lesions (reference group; n = 5994). Overall, 0.6% of the patients in the experimental group had clinically insignificant prostate cancer compared with 1.2% of those in the reference group (RR, 0.46). The experimental group had a 0.81 relative risk of clinically significant prostate cancer compared with the reference group. In the reference group, systematic biopsy alone detected 10 patients with clinically significant intermediate-risk tumors.
Avoiding the use of systematic biopsy and only using MRI-directed targeted biopsy for the screening and early detection of prostate cancer in patients with high PSA levels led to a significant reduction in the risk of overdiagnosis but at the cost of delayed detection of a small proportion of intermediate-risk tumor cases.
This abstract is available on the publisher's site.
Screening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown.
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.
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.
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.).
Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only
N. Engl. J. Med 2022 Dec 08;387(23)2126-2137, J Hugosson, M Månsson, J Wallström, U Axcrona, SV Carlsson, L Egevad, K Geterud, A Khatami, K Kohestani, CG Pihl, A Socratous, J Stranne, RA Godtman, M Hellström