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Bending the Curve Trial by Trial
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STHLM3-MRI

MRI-Targeted or Standard Biopsy in Prostate Cancer Screening

N = 1,532NCT03377881

Population
Men aged 50-74 years invited from the general population (12,750 enrolled); the 1532 with PSA 3 ng/mL or higher were randomised to biopsy.
Design
Population-based noninferiority trial of prostate cancer screening by invitation: men aged 50-74 years from the general population were invited by mail; participants with PSA 3 ng/mL or higher were randomly assigned 2:3 to standard biopsy or to MRI with targeted and standard biopsy if the MRI suggested prostate cancer.
Primary endpoint
Detection of clinically significant prostate cancer
Arms
  • Standard biopsy (control, n = 603): Standard biopsy
  • MRI, targeted plus standard biopsy (experimental, n = 929): MRI, with targeted and standard biopsy if the MRI results suggested prostate cancer
People
Eklund M, STHLM3 consortium
Δ Detection of clinically significant prostate cancer+3 pointsΔ Detection of clinically insignificant prostate cancer−8 points
Show the numbers
Results reported for STHLM3-MRI
EndpointAnalysisMRI, targeted plus standard biopsyStandard biopsyEffect
Detection of clinically significant prostate cancerIntention-to-treat population (929 experimental biopsy group; 603 standard biopsy group)Proportion of men in whom clinically significant cancer (Gleason score 7 or higher) was diagnosed.primaryEklund 202121%18%P<0.001 (noninferiority)192 vs 106 men; difference 3 percentage points (95% CI -1 to 7).
Detection of clinically insignificant prostate cancerIntention-to-treat population (929 experimental biopsy group; 603 standard biopsy group)Proportion of men in whom clinically insignificant cancer (Gleason score 6) was diagnosed (key secondary outcome).primaryEklund 20214%12%73 vs 41 participants; difference -8 percentage points (95% CI -11 to -5).
Results reported for STHLM3-MRI
EndpointAnalysisMRI, targeted plus standard biopsyStandard biopsyEffect
Detection of clinically significant prostate cancerIntention-to-treat population (929 experimental biopsy group; 603 standard biopsy group)Proportion of men in whom clinically significant cancer (Gleason score 7 or higher) was diagnosed.primaryEklund 202121%18%P<0.001 (noninferiority)192 vs 106 men; difference 3 percentage points (95% CI -1 to 7).
Detection of clinically insignificant prostate cancerIntention-to-treat population (929 experimental biopsy group; 603 standard biopsy group)Proportion of men in whom clinically insignificant cancer (Gleason score 6) was diagnosed (key secondary outcome).primaryEklund 20214%12%73 vs 41 participants; difference -8 percentage points (95% CI -11 to -5).
Primary publication: Eklund M, Jäderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, et al. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021;385(10):908-920. PubMedDOI

Appears in

Sources

  1. Eklund M, Jäderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, et al. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021;385(10):908-920.

    PubMedDOI