Results of EAU RF PRECISION study lead to changes in international prostate cancer diagnosis guidelines

10 October 2019 Dr. Veeru Kasivisvanathan

The PRECISION Trial is a landmark study evaluating MRI and MRI-targeted biopsy compared to standard TRUS biopsy in men with suspected prostate cancer who have not had a biopsy before. The study was published in the New England Journal of Medicine and was awarded the Fritz Schröder EAU Prostate Cancer Research Award in 2019. The work has helped to influence the EAU 2019 guidelines for prostate cancer diagnosis.

Background
The PRECISION (PRostate Evaluation for Clinically Important disease, Sampling using Image-guidance Or Not?) study is an international study that was reported in 2018. Prior to the publication of the PRECISION study, the role of multiparametric MRI in the diagnosis of prostate cancer in biopsy-naïve men was uncertain, with national and EAU guidelines only recommending its use in men with a prior negative prostate biopsy and ongoing suspicion of cancer. PRECISION aimed to assess whether multiparametric MRI and a targeted biopsy only (MRI± TB) is non-inferior to transrectal ultrasound guided (TRUS) biopsy in the detection of clinically significant prostate cancer in biopsy-naive men.

Study Design
The study is an international multi-centre randomized controlled trial, in which 500 men, who had been referred with clinical suspicion of prostate cancer without prior biopsy, were randomised to either standard 12-core TRUS biopsy or a MPMRI arm.

In the MPMRI arm, areas of the prostate were scored according to the PIRADsv2 scoring system.

Areas scoring 3, 4 or 5 underwent targeted biopsy only. Up to three MRI-suspicious areas were targeted with a maximum of 4 cores per target, leading to a maximum of up to 12 cores per patient in the MRI arm. Visual registration or software-assisted registration were permitted.

Outcomes
Primary Outcome:
Proportion of men with clinically significant cancer (Gleason 3 + 4 or greater) detected.

Secondary Outcomes included:

  1. Proportion of men with clinically insignificant cancer (Gleason 3 + 3) detected
  2. Proportion of men with negative MPMRI who avoid biopsy
  3. Maximum cancer core length of most involved biopsy core

Key patient inclusion criteria:

  1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
  2. Serum PSA ≤ 20ng/ml\
  3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)

Key patient exclusion criteria:

  1. Prior prostate biopsy
  2. Prior treatment for prostate cancer
  3. Contraindication to MRI or prostate biopsy

Key findings
One third of men (71/252, 28%) avoided biopsy in the MRI arm. Clinically significant cancer was detected in 95 (38%) of 252 men in the MRI ± TB arm compared to 64 (26%) of 248 men randomized to TRUS-biopsy on the intention-to-treat analysis. Adjusting for centre effects, the absolute difference (MRI ± TB vs. TRUS-biopsy) in the proportion of men diagnosed with clinically significant prostate cancer was 11.7% (2-sided 95% CI 3.6 to 19.8; 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, these results also indicated that MRI ± TB was superior to TRUS-biopsy. MRI ± TB also diagnosed fewer men with insignificant cancer than TRUS biopsy (23/252 (9%) vs. 55/248 (22%), p < 0.001).

The potential implications of this trial:

  • Introduction of an alternative prostate cancer diagnostic pathway in biopsy naive men
  • An increase in the number of patients with clinically significant cancer diagnosed
  • A reduction in the over-diagnosis of clinically insignificant prostate cancer
  • A reduction in the number of patients undergoing prostate biopsy
  • A reduction in the number of biopsy cores taken per patient
  • A reduction in biopsy-related sepsis, pain and other side effects

Changes in international guidelines
As a result of the PRECISION trial and a number of other high-profile studies, the 2019 European Association of Urology and 2019 UK National Institute for Health and Care Excellence Guidelines in Prostate Cancer now recommend performing an MRI before prostate biopsy in biopsy-naive men. The information from the MRI should be used to influence how the prostate biopsy is performed by the addition of MRI-targeted prostate biopsy. Both organisations recommend considering avoiding a biopsy in men with low clinical risk of prostate cancer who have a non-suspicious MRI after an informed discussion with the patient.

Funding
The EAU Research Foundation provided its web-based database management system for collection of patient data and provided all sites with patient recruited funding. We would particularly like to acknowledge Wim Witjes, Christien Caris and Joke van Egmond from the EAU Research Foundation for their important contribution.

Veeru Kasivisvanathan was funded by a UK NIHR Doctoral Research Fellowship (DRF-2014-07-146) and UK sites were funded by the NIHR Clinical Research Network.

Read the full article on page 17 of the August/September 2019 edition of European Urology Today (EUT).

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