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Published report from the trial registered as ISRCTN94604465, in New England Journal of Medicine (2022), chosen as the most cited paper whose own text cites the registry id.
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.).
Indexed on Europe PMC as PubMed record 36477032 (DOI 10.1056/nejmoa2209454). Its abstract cites the registry id ISRCTN94604465, which is how it was matched to this trial; no figure has been checked by an editor.
This is the paper Europe PMC returns for registry id ISRCTN94604465 with the most citations, so it is the natural first reading for anyone following the trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
The evidence that put a scan in front of the biopsy. It reduces the number of men who are biopsied at all, reduces the number of harmless cancers found, and increases the number of dangerous ones, which is the only combination that improves a screening pathway on both sides at once.
The evidence that prostate-specific antigen screening works, stated together with the price. It is the reason screening programmes are debated rather than simply adopted, and the reason every subsequent proposal, from magnetic resonance imaging first to risk-model invitation, is judged on whether it keeps the mortality benefit while reducing the 48.
Shares GÖTEBORG-2 (MRI-based prostate cancer screening), Polygenic risk score (PRS), PROMIS: diagnostic accuracy of multiparametric MRI and TRUS biopsy in prostate cancer, Number needed to screen (and number needed to diagnose).
Shares Polygenic risk score (PRS), PI-RADS (Prostate Imaging Reporting and Data System), Judge a prostate screening programme on metastatic presentation, not on incidence or mortality, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch.
Shares PROMIS: diagnostic accuracy of multiparametric MRI and TRUS biopsy in prostate cancer, PI-RADS (Prostate Imaging Reporting and Data System), Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch, New England Journal of Medicine.
Shares ERSPC: screening and prostate cancer mortality in a randomised European study, Judge a prostate screening programme on metastatic presentation, not on incidence or mortality, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch, Prostate cancer.
Shares Number needed to screen (and number needed to diagnose), ERSPC: screening and prostate cancer mortality in a randomised European study, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch, Prostate cancer.
Shares Number needed to screen (and number needed to diagnose), ERSPC: screening and prostate cancer mortality in a randomised European study, Judge a prostate screening programme on metastatic presentation, not on incidence or mortality, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch.
Shares Polygenic risk score (PRS), Number needed to screen (and number needed to diagnose), ERSPC: screening and prostate cancer mortality in a randomised European study, Judge a prostate screening programme on metastatic presentation, not on incidence or mortality.
Shares Polygenic risk score (PRS), Judge a prostate screening programme on metastatic presentation, not on incidence or mortality, Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch, Prostate cancer.