STHLM3MR-2
Trial question
Is MRI with targeted biopsy noninferior to standard biopsy in prostate cancer screening?
Study design
Multi-center
Open label
RCT
Population
1532 male patients.
Inclusion criteria: men aged 50 to 74 years with PSA levels ≥ 3 ng/mL.
Key exclusion criteria: previous diagnosis of prostate cancer; a prostate biopsy within 60 days of invitation; contraindication to MRI; severe illness.
Interventions
N=929 MRI-targeted biopsy (MRI with targeted and standard biopsy if the MRI results suggested prostate cancer).
N=603 standard biopsy (systematic biopsy of the prostate if PSA ≥ 3 ng/mL).
Primary outcome
Detection of clinically significant cancer
21%
18%
21.0 %
15.8 %
10.5 %
5.3 %
0.0 %
MRI-targeted
biopsy
Standard
biopsy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in detection of clinically significant cancer (21% vs. 18%; AD 3%, 95% CI -1 to 7).
Secondary outcomes
Significant decrease in detection of clinically insignificant cancer (4% vs. 12%; ARD -8, 95% CI -11 to -5).
Significant decrease in benign biopsy findings (11% vs. 43%; ARD -32, 95% CI -36 to -27).
Safety outcomes
No significant difference in post-biopsy infections and hospitalization.
Conclusion
In men aged 50 to 74 years with PSA levels ≥ 3 ng/mL, MRI-targeted biopsy was noninferior to standard biopsy with respect to detection of clinically significant cancer.
Reference
Martin Eklund, Fredrik Jäderling, Andrea Discacciati et al. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920.
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