The GÖTEBORG Prostate Cancer Screening 2 Trial: a Prospective, Randomised, Population-based Prostate Cancer Screening Trial with Prostate-specific Antigen Testing Followed by Magnetic Resonance Imaging of the Prostate

Overview

Journal Scand J Urol

Specialty Urology

Date 2021 Feb 22

PMID 33612068

Citations 15

Authors

Kimia Kohestani

Marianne Mansson

Rebecka Arnsrud Godtman

Johan Stranne

Jonas Wallstrom

Sigrid Carlsson

Mikael Hellstrom

Jonas Hugosson

Affiliations

Soon will be listed here.

Abstract

Objective: To describe the study design of the GÖTEBORG prostate cancer screening (PC) 2 (Göteborg-2), a prospective, randomised, population-based trial of PC screening. This trial evaluates whether prostate-specific antigen (PSA) testing followed by 3 Tesla prostate magnetic resonance imaging (MRI) and targeted biopsy can reduce overdiagnosis, while maintaining the detection of clinically significant cancer, compared to PSA-screening and systematic biopsy.

Materials And Methods: A random sample of men 50-60 years in the Göteborg area, Sweden, identified from the Total Population Register, were randomised to either a screening or control group (CG). Participants in the screening group (SG) were further randomised into one of three arms: (1) PSA-test; if PSA ≥ 3 ng/mL, then MRI and systematic biopsy, plus targeted biopsy to suspicious lesions as per Prostate Imaging - Reporting and Data System, version 2 (PI-RADSv2) 3-5; (2) PSA-test; if PSA ≥ 3 ng/mL, then MRI, and targeted biopsy only if PI-RADSv2 3-5; (3) identical to Arm 2, except lower PSA-cut-off ≥1.8 ng/mL. The primary outcome is the detection rate of clinically insignificant PC (defined as Gleason Score 3 + 3 [Grade Group 1]) comparing all men with PSA ≥ 3 ng/mL in Arm 1 Arm 2 + 3.

Results: Randomisation and enrolment started in September 2015. Accrual has hitherto resulted in 38,770 men randomised to the SG. The participation rate is 50%. Invitation to the first screening round was completed in June 2020.

Conclusions: The Göteborg-2 trial will provide new knowledge about the performance of prostate MRI in a screening setting.

Citing Articles

Screening for prostate cancer: evidence, ongoing trials, policies and knowledge gaps.

Bratt O, Auvinen A, Arnsrud Godtman R, Hellstrom M, Hugosson J, Lilja H BMJ Oncol. 2025; 2(1):e000039.

PMID: 39886507 PMC: 11203092. DOI: 10.1136/bmjonc-2023-000039.

[Early detection of prostate cancer-individualized, risk-adapted and successful].

Hubner A, Busshoff I, Lakes J, Al-Monajjed R, Radtke J, Albers P Urologie. 2024; 64(1):14-23.

PMID: 39609267 DOI: 10.1007/s00120-024-02478-1.

How a population-based cohort of men estimate lifetime risk of prostate cancer in a survey before entering a prostate cancer screening trial in Sweden?.

Palmstedt E, Mansson M, Kollberg K, Carlsson S, Hellstrom M, Wallstrom J BMJ Open. 2024; 14(8):e083562.

PMID: 39153780 PMC: 11331866. DOI: 10.1136/bmjopen-2023-083562.

Understanding the Barriers to Prostate Cancer Population-Based Early Detection Programs: The PRAISE-U BEST Survey.

Beyer K, Leenen R, Venderbos L, Helleman J, Remmers S, Vasilyeva V J Pers Med. 2024; 14(7).

PMID: 39064006 PMC: 11277738. DOI: 10.3390/jpm14070751.

Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform.

Hyndman M, Paproski R, Kinnaird A, Fairey A, Marks L, Pavlovich C NPJ Digit Med. 2024; 7(1):163.

PMID: 38902526 PMC: 11190196. DOI: 10.1038/s41746-024-01167-9.

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