The PRECISION study: Prostate evaluation for clinically important disease, sampling using image-guidance or not? (NCT02380027)
BAUS ePoster online library. Kasivisvanathan V.
Jun 26, 2018; 211337
Disclosure(s): NIHR Doctoral Fellowship Award European Association of Urology Research Foundation funding
Mr. Veeru Kasivisvanathan
Mr. Veeru Kasivisvanathan
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Introduction: PRECISION aimed to evaluate whether multiparametric MRI and a targeted biopsy only (MRI±TB) was non-inferior to TRUS biopsy in the detection of clinically significant prostate cancer in biopsy naïve men

Patients & Methods: PRECISION was a randomised, non-inferiority trial, carried out in 25 centres in 11 countries. 500 men were randomly allocated to 10-12 core TRUS-biopsy or MRI±TB. Men randomised to MRI±TB underwent MRI followed by targeted biopsy alone (without standard cores) if the PIRADSv2 score was ≥3. Men with a PIRADSv2 score of 1-2 were not offered biopsy. The primary outcome was the proportion of men diagnosed with clinically significant cancer (Gleason grade ≥ 3+4).

Results: One third of men avoided biopsy in the MRI arm (71/252, 28%). Clinically significant cancer was detected in 95 (38%) of 252 men in the MRI±TB arm compared to 64 (26%) of 248 men randomised to TRUS-biopsy (intention-to-treat analysis). Adjusting for centre effects, the absolute difference (MRI±TB versus TRUS-biopsy) in the proportion of men diagnosed with clinically significant prostate cancer was 11.8% (2-sided 95% CI 3.7 to 20.0; p = 0.005). The lower bound of the 95% CI for the difference is greater than -5% therefore MRI±TB was non-inferior to TRUS biopsy. Furthermore, the range of 95% CI was consistent with a claim of superiority of MRI±TB over TRUS-biopsy.

Conclusion: An MRI-targeted approach in biopsy naive men resulted in greater detection of clinically significant disease, less detection of insignificant disease and required fewer biopsies.
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