This nonfiction is disposable to subscribers. Subscribe now. Already person an account? Sign in
Original ArticleFree Preview
List of authors.- Jonas Hugosson, M.D., Ph.D.,
- Marianne Månsson, Ph.D.,
- Jonas Wallström, M.D., Ph.D.,
- Ulrika Axcrona, M.D., Ph.D.,
- Sigrid V. Carlsson, M.D, Ph.D., M.P.H.,
- Lars Egevad, M.D., Ph.D.,
- Kjell Geterud, M.D., Ph.D.,
- Ali Khatami, M.D., Ph.D.,
- Kimia Kohestani, M.D., Ph.D.,
- Carl-Gustaf Pihl, M.D.,
- Andreas Socratous, M.D.,
- Johan Stranne, M.D., Ph.D.,
- Rebecka Arnsrud Godtman, M.D., Ph.D.,
- and Mikael Hellström, M.D., Ph.D.
- for the GÖTEBORG-2 Trial Investigators*
Abstract
Background
Screening for prostate crab is burdened by a precocious complaint of overdiagnosis. The astir due algorithm for population-based screening is unknown.
Methods
Download a PDF of the Research Summary.
We invited 37,887 men who were 50 to 60 years of property to acquisition regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter oregon higher underwent magnetic resonance imaging (MRI) of the prostate; 1 3rd of the participants were randomly assigned to a notation radical that underwent systematic biopsy arsenic good arsenic targeted biopsy of suspicious lesions shown connected MRI. The remaining participants were assigned to the experimental radical and underwent MRI-targeted biopsy only. The superior result was clinically insignificant prostate cancer, defined arsenic a Gleason people of 3+3. The secondary result was clinically important prostate cancer, defined arsenic a Gleason people of astatine slightest 3+4. Safety was besides assessed.
Results
Of the men who were invited to acquisition screening, 17,980 (47%) participated successful the trial. A full of 66 of the 11,986 participants successful the experimental radical (0.6%) received a diagnosis of clinically insignificant prostate cancer, arsenic compared with 72 of 5994 participants (1.2%) successful the notation group, a quality of −0.7 percent points (95% assurance interval [CI], −1.0 to −0.4; comparative risk, 0.46; 95% CI, 0.33 to 0.64; P<0.001). The comparative hazard of clinically important prostate crab successful the experimental radical arsenic compared with the notation radical was 0.81 (95% CI, 0.60 to 1.1). Clinically important crab that was detected lone by systematic biopsy was diagnosed successful 10 participants successful the notation group; each cases were of intermediate hazard and progressive chiefly low-volume illness that was managed with progressive surveillance. Serious adverse events were uncommon (<0.1%) successful the 2 groups.
Conclusions
The avoidance of systematic biopsy successful favour of MRI-directed targeted biopsy for screening and aboriginal detection successful persons with elevated PSA levels reduced the hazard of overdiagnosis by fractional astatine the outgo of delaying detection of intermediate-risk tumors successful a tiny proportionality of patients. (Funded by Karin and Christer Johansson’s Foundation and others; GÖTEBORG-2 ISRCTN Registry number, ISRCTN94604465.)
QUICK TAKE VIDEO SUMMARY
Omitting Systematic Biopsy successful Prostate Cancer Screening
01:59
Funding and Disclosures
Supported by the Karin and Christer Johansson’s Foundation, the Swedish Cancer Society, grants from the Swedish authorities nether the statement betwixt the Swedish authorities and the region councils, the ALF-agreement (number 966044), the Swedish Research Council, Biocare, Regional Cancer Center Western Region Sweden, the Swedish Prostate Cancer Association, AFA Insurance, and the Nordic Cancer Union. Dr. Carlsson received enactment from the National Institutes of Health National Cancer Institute to Memorial Sloan Kettering Cancer Center done the Cancer Center Support Grant (awards numbers, P30 CA008748 and K22-CA234400).
Disclosure forms provided by the authors are disposable with the afloat substance of this nonfiction astatine NEJM.org.
A data sharing statement provided by the authors is disposable with the afloat substance of this nonfiction astatine NEJM.org.
We convey Helén Ahlgren, caregiver Maria Nyberg, and Emelie Tubbin of the GÖTEBORG-2 survey administration; nurses Linda Svensson and Jenny Fernström for assistance during the objective examinations of participants, including prostate biopsy; caregiver radiographers Stig Eriksson and Erica De Coursey for method assistance with MRIs; Prof. Freddie Hamdy, Prof. Sophia Zackrisson, and Prof. Olof Akre for their invaluable publication to the advisory committee; and Dr. Fredrik Jäderling for participating successful the outer validation of MRI results.
Author Affiliations
From the Departments of Urology (J.H., A.K., K.K., J.S., R.A.G.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (C.-G.P.), Sahlgrenska University Hospital–Sahlgrenska Academy astatine Gothenburg University, and the Department of Urology, Sahlgrenska Academy astatine Gothenburg University (J.H., M.M., S.V.C.), Gothenburg, and the Department of Oncology–Pathology, Karolinska Institute, Stockholm (L.E.) — each successful Sweden; the Departments of Pathology and Molecular Oncology, Oslo University Hospital–Radiumhospitalet, Oslo (U.A.); and the Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York (S.V.C.).
Dr. Hugosson tin beryllium contacted astatine [email protected] oregon astatine the Department of Urology, Sahlgrenska University Hospital, Bruna Stråken 11b, SE-41345 Gothenburg, Sweden.
A database of the GÖTEBORG-2 proceedings investigators is provided successful the Supplementary Appendix, disposable astatine NEJM.org.
English (US)