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Göteborg-2

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Results after Four Years of Screening for Prostate Cancer with PSA and MRI (Göteborg-2 population-based trial)

Population
Men aged 50 to 60 years invited to PSA screening (6575 in the MRI-targeted biopsy group and 6578 in the systematic biopsy group as reported in the results).
Design
Population-based trial started in 2015: men aged 50 to 60 years were invited to PSA screening and men with PSA 3 ng/mL or higher had prostate MRI. As worded in the abstract, men were randomly assigned to a systematic biopsy group (systematic biopsy and, if MRI was suspicious, targeted biopsy) or an MRI-targeted biopsy group (MRI-targeted biopsy only); the abstract does not say at which step randomisation took place, and the registry entry describes a more complex allocation. Men were invited for repeat screening 2, 4 or 8 years later, depending on PSA level.
Primary endpoint
Detection of clinically insignificant prostate cancer
Arms
  • Systematic biopsy (control, n = 6,578): Systematic biopsy, plus targeted biopsy if MRI showed suspicious lesions
  • MRI-targeted biopsy only (experimental, n = 6,575): MRI-targeted biopsy only
People
Hugosson J
Δ Cumulative incidence of prostate cancer−1.7 points
Show the numbers
Results reported for Göteborg-2
EndpointAnalysisMRI-targeted biopsy onlySystematic biopsyEffect
Cumulative incidence of prostate cancerMen in each group (6575 MRI-targeted biopsy; 6578 systematic biopsy); analysis set not otherwise stated in the abstractProportion of men in whom prostate cancer had been detected after a median follow-up of 3.9 years.primarymedian follow-up 3.9 yearsHugosson 20242.8%4.5%298 vs 185 men. Primary outcome, clinically insignificant (ISUP grade 1) cancer: relative risk 0.43 (95% CI 0.32-0.57; P<0.001) for MRI-targeted versus systematic biopsy (a relative risk, not a hazard ratio), lower at repeat rounds than in the first round (0.25 vs 0.49). Clinically significant (ISUP grade 2 or higher): relative risk 0.84 (95% CI 0.66-1.07). Advanced or high-risk cancers (screen-detected or interval): 15 vs 23, relative risk 0.65 (95% CI 0.34-1.24).
Results reported for Göteborg-2
EndpointAnalysisMRI-targeted biopsy onlySystematic biopsyEffect
Cumulative incidence of prostate cancerMen in each group (6575 MRI-targeted biopsy; 6578 systematic biopsy); analysis set not otherwise stated in the abstractProportion of men in whom prostate cancer had been detected after a median follow-up of 3.9 years.primarymedian follow-up 3.9 yearsHugosson 20242.8%4.5%298 vs 185 men. Primary outcome, clinically insignificant (ISUP grade 1) cancer: relative risk 0.43 (95% CI 0.32-0.57; P<0.001) for MRI-targeted versus systematic biopsy (a relative risk, not a hazard ratio), lower at repeat rounds than in the first round (0.25 vs 0.49). Clinically significant (ISUP grade 2 or higher): relative risk 0.84 (95% CI 0.66-1.07). Advanced or high-risk cancers (screen-detected or interval): 15 vs 23, relative risk 0.65 (95% CI 0.34-1.24).
Primary publication: Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, et al. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024;391(12):1083-1095. PubMedDOI

Appears in

Sources

  1. Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, et al. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024;391(12):1083-1095.

    PubMedDOI