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A nationwide analysis of risk of prostate cancer diagnosis and mortality following an initial negative TRUS-Biopsy with long-term follow-up

  • Sandra Miriam Kawa,
  • Hein Vincent Stroomberg,
  • Signe Benzon Larsen,
  • John Thomas Helgstrand,
  • Birgitte Grønkær Toft,
  • Andrew Julian Vickers,
  • Klaus Brasso,
  • Martin Andreas Røder

Publication: Journal of Urology, February 2022

Purpose

MRI targeted prostate biopsy has been shown to find many high-grade prostate cancers in men with concurrent negative transrectal ultrasound (TRUS) systematic biopsy. The oncologic risk of such tumors can be explored by looking at long-term outcomes of men with negative TRUS-biopsy followed without MRI. The aim was to analyze the mortality after initial and second negative TRUS-biopsy.

Materials and methods

All men who underwent initial TRUS-biopsies between January 1st, 1995 and December 31st, 2016 in Denmark were included. A total of 37,214 men had a negative initial TRUS-biopsy and 6,389 underwent a re-biopsy. Risk of cause-specific mortality was analyzed with competing risks. Diagnosis of Gleason score≥7 prostate cancer following negative biopsies was analyzed with multivariable logistic regression including time to re-biopsy, PSA, age and digital rectal examination.

Results

The 15-year prostate cancer-specific mortality was 1.9% (95% CI: 1.7 – 2.1). Prostate cancer-specific mortality was 1.3% (95% CI: 0.9-1.6) and 4.6% (95% CI: 3.4 – 5.8) for men with PSA<10 ng/ml and>20 ng/ml, respectively. 12% of the TRUS re-biopsies were Gleason score≥7 and risk of Gleason score≥7 increased with longer time to re-biopsy (p<0.001). Mortality after re-biopsy was similar to after initial biopsy.

Conclusions

Men with negative TRUS-biopsies have a very low prostate cancer-specific mortality, especially with PSA<10. This raises serious questions about the routine use of MRI-targeting for initial prostate biopsy and suggests that MRI-targeting should only be recommended for men with PSA>10 ng/ml after negative biopsy.