Results after Four Years of Screening for Prostate Cancer with PSA and MRI.

Humans Male Prostatic Neoplasms / diagnostic imaging Prostate-Specific Antigen / blood Middle Aged Magnetic Resonance Imaging Early Detection of Cancer Prostate / pathology Follow-Up Studies Neoplasm Grading Biopsy Image-Guided Biopsy

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
26 Sep 2024
Historique:
medline: 25 9 2024
pubmed: 25 9 2024
entrez: 25 9 2024
Statut: ppublish

Résumé

Data on the efficacy and safety of screening for prostate cancer with magnetic resonance imaging (MRI) are needed from studies of follow-up screening. In a population-based trial that started in 2015, we invited men who were 50 to 60 years of age to undergo prostate-specific antigen (PSA) screening. Men with a PSA level of 3 ng per milliliter or higher underwent MRI of the prostate. Men were randomly assigned to the systematic biopsy group, in which they underwent systematic biopsy and, if suspicious lesions were found on MRI, targeted biopsy, or the MRI-targeted biopsy group, in which they underwent MRI-targeted biopsy only. At each visit, men were invited for repeat screening 2, 4, or 8 years later, depending on the PSA level. The primary outcome was detection of clinically insignificant (International Society of Urological Pathology [ISUP] grade 1) prostate cancer; detection of clinically significant (ISUP grade ≥2) cancer was a secondary outcome, and detection of clinically advanced or high-risk (metastatic or ISUP grade 4 or 5) cancer was also assessed. After a median follow-up of 3.9 years (approximately 26,000 person-years in each group), prostate cancer had been detected in 185 of the 6575 men (2.8%) in the MRI-targeted biopsy group and 298 of the 6578 men (4.5%) in the systematic biopsy group. The relative risk of detecting clinically insignificant cancer in the MRI-targeted biopsy group as compared with the systematic biopsy group was 0.43 (95% confidence interval [CI], 0.32 to 0.57; P<0.001) and was lower at repeat rounds of screening than in the first round (relative risk, 0.25 vs. 0.49); the relative risk of a diagnosis of clinically significant prostate cancer was 0.84 (95% CI, 0.66 to 1.07). The number of advanced or high-risk cancers detected (by screening or as interval cancer) was 15 in the MRI-targeted biopsy group and 23 in the systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24). Five severe adverse events occurred (three in the systematic biopsy group and two in the MRI-targeted biopsy group). In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN registry number, ISRCTN94604465.).

Sections du résumé

BACKGROUND BACKGROUND
Data on the efficacy and safety of screening for prostate cancer with magnetic resonance imaging (MRI) are needed from studies of follow-up screening.
METHODS METHODS
In a population-based trial that started in 2015, we invited men who were 50 to 60 years of age to undergo prostate-specific antigen (PSA) screening. Men with a PSA level of 3 ng per milliliter or higher underwent MRI of the prostate. Men were randomly assigned to the systematic biopsy group, in which they underwent systematic biopsy and, if suspicious lesions were found on MRI, targeted biopsy, or the MRI-targeted biopsy group, in which they underwent MRI-targeted biopsy only. At each visit, men were invited for repeat screening 2, 4, or 8 years later, depending on the PSA level. The primary outcome was detection of clinically insignificant (International Society of Urological Pathology [ISUP] grade 1) prostate cancer; detection of clinically significant (ISUP grade ≥2) cancer was a secondary outcome, and detection of clinically advanced or high-risk (metastatic or ISUP grade 4 or 5) cancer was also assessed.
RESULTS RESULTS
After a median follow-up of 3.9 years (approximately 26,000 person-years in each group), prostate cancer had been detected in 185 of the 6575 men (2.8%) in the MRI-targeted biopsy group and 298 of the 6578 men (4.5%) in the systematic biopsy group. The relative risk of detecting clinically insignificant cancer in the MRI-targeted biopsy group as compared with the systematic biopsy group was 0.43 (95% confidence interval [CI], 0.32 to 0.57; P<0.001) and was lower at repeat rounds of screening than in the first round (relative risk, 0.25 vs. 0.49); the relative risk of a diagnosis of clinically significant prostate cancer was 0.84 (95% CI, 0.66 to 1.07). The number of advanced or high-risk cancers detected (by screening or as interval cancer) was 15 in the MRI-targeted biopsy group and 23 in the systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24). Five severe adverse events occurred (three in the systematic biopsy group and two in the MRI-targeted biopsy group).
CONCLUSIONS CONCLUSIONS
In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer, and the associated risk of having incurable cancer diagnosed at screening or as interval cancer was very low. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN registry number, ISRCTN94604465.).

Identifiants

DOI: 10.1056/NEJMoa2406050 PMID: 39321360
pubmed: 39321360
doi: 10.1056/NEJMoa2406050
doi:

Substances chimiques

Prostate-Specific Antigen EC 3.4.21.77

Banques de données

ISRCTN
['ISRCTN94604465']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1083-1095

Subventions

Organisme : Cancerfonden
ID : 22-2041
Organisme : Vetenskapsrådet
ID : 2020-022477

Informations de copyright

Copyright © 2024 Massachusetts Medical Society.

Auteurs

Jonas Hugosson (J)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Rebecka Arnsrud Godtman (RA)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Jonas Wallstrom (J)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).
ORCID: 0000-0002-4453-6718

Ulrika Axcrona (U)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Anders Bergh (A)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Lars Egevad (L)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Kjell Geterud (K)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Ali Khatami (A)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Andreas Socratous (A)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Vasiliki Spyratou (V)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Linda Svensson (L)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Johan Stranne (J)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Marianne Månsson (M)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

Mikael Hellstrom (M)

From the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S., M.M.) and Radiology (J.W., K.G., A.S., M.H.), Institution of Clinical Sciences, and the Department of Pathology, Institute of Biomedicine (V.S.), Sahlgrenska Academy, University of Gothenburg, the Departments of Urology (J.H., R.A.G., A.K., L.S., J.S.), Radiology (J.W., K.G., A.S., M.H.), and Pathology (V.S.), Sahlgrenska University Hospital, Gothenburg, the Department of Pathology, Umeå University Hospital, Umeå (A.B.), and the Department of Oncology-Pathology, Karolinska Institute, Stockholm (L.E.) - all in Sweden; and the Departments of Pathology and Molecular Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo (U.A.).

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Results after Four Years of Screening for...
questionsmedicales.fr › Maladies urogénitales › Tumeurs de l'appareil urogénital › Tumeurs de l'appareil génital mâle › Tumeurs de la prostate › Results after Four Years of Screening for...
questionsmedicales.fr › Facteurs biologiques › Marqueurs biologiques › Marqueurs biologiques tumoraux › Antigène spécifique de la prostate › Results after Four Years of Screening for...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Results after Four Years of Screening for...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Results after Four Years of Screening for...
questionsmedicales.fr › Diagnostic › Diagnostic précoce › Dépistage précoce du cancer › Results after Four Years of Screening for...
questionsmedicales.fr › Tissus › Glandes exocrines › Prostate › Results after Four Years of Screening for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études de suivi › Results after Four Years of Screening for...
questionsmedicales.fr › Diagnostic › Pronostic › Grading des tumeurs › Results after Four Years of Screening for...
questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytodiagnostic › Biopsie › Results after Four Years of Screening for...
questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytodiagnostic › Biopsie › Biopsie guidée par l'image › Results after Four Years of Screening for...