The New England Journal of MedicineResults after Four Years of Screening for Prostate Cancer with PSA and MRI

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This study evaluates the efficacy and safety of using magnetic resonance imaging (MRI) in conjunction with prostate-specific antigen (PSA) screening for prostate cancer detection. The trial, which began in 2015, compared outcomes between men who underwent systematic biopsy and those who had MRI-targeted biopsy only. The findings provide valuable insights into the potential benefits and risks of MRI-targeted biopsy in reducing the detection of clinically insignificant prostate cancer while maintaining low rates of advanced cancer detection.

Study Design:

• Participants: Men aged 50 to 60 years.
• Screening Method: PSA screening followed by MRI for those with PSA levels ≥3 ng/mL.
• Groups:
  • Systematic Biopsy Group: Underwent systematic biopsy and MRI-targeted biopsy if suspicious lesions were found.
  • MRI-Targeted Biopsy Group: Underwent MRI-targeted biopsy only.
• Follow-Up: Median follow-up of 3.9 years, with repeat screenings every 2, 4, or 8 years based on PSA levels.
• Primary Outcome: Detection of clinically insignificant prostate cancer (ISUP grade 1).
• Secondary Outcomes: Detection of clinically significant (ISUP grade ≥2) and advanced or high-risk (metastatic or ISUP grade 4 or 5) prostate cancer.

Key Findings:

• Detection Rates:
  • Clinically insignificant cancer: 2.8% in MRI-targeted biopsy group vs. 4.5% in systematic biopsy group.
  • Clinically significant cancer: Relative risk of 0.84 (95% CI, 0.66 to 1.07).
  • Advanced or high-risk cancer: 15 cases in MRI-targeted biopsy group vs. 23 cases in systematic biopsy group (relative risk, 0.65; 95% CI, 0.34 to 1.24).
• Adverse Events: Five severe adverse events (three in systematic biopsy group, two in MRI-targeted biopsy group).
• Implications: Omitting biopsy in patients with negative MRI results significantly reduces the diagnosis of clinically insignificant prostate cancer without increasing the risk of advanced cancer detection.

HCN Medical Memo
This study highlights the potential of MRI-targeted biopsy to reduce unnecessary diagnoses of clinically insignificant prostate cancer, thereby minimizing overtreatment. The findings suggest that MRI-targeted biopsy can be a safer and more efficient approach in prostate cancer screening, with a low risk of missing advanced cancers.

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