MRI-TARGETED, FUSION OR COGNITIVE ULTRASOUND GUIDED BIOPSY TO DETECT PROSTATE CANCER (FOCUS-PC STUDY)

Document Type

Conference Proceeding

Publication Date

5-1-2025

Publication Title

J Urol

Keywords

prostate specific antigen, cognition, comparative effectiveness, conference abstract, controlled study, diagnosis, diagnostic test accuracy study, diagnostic value, digital rectal examination, finger malformation, Gleason score, human, human tissue, lesion volume, local anesthesia, male, MRI guided biopsy, MRI scanner, multiparametric magnetic resonance imaging, nuclear magnetic resonance imaging, operating room, power analysis, prostate, prostate biopsy, prostate cancer, randomized controlled trial, sedation, systematic review, ultrasound, ultrasound guided biopsy, urban area

Abstract

Background: MRI-targeted biopsy can be performed using either the software-based fusion of MRI and ultrasound images (fusion) or by visually targeting the MRI-detected lesion using ultrasound guidance (cognitive). Published studies demonstrate variable results of cognitive and fusion targeting technique which are influenced by biopsy approach, MRI quality, PIRADS and lesion size. Further, majority of the studies are retrospective, with tremendous heterogeneity and high risk of bias. While several centers and experts prefer cognitive targeting, especially for transperineal approach, the current literature is devoid of high-level evidence to support one targeting technique over the other. To date, there have not been any sufficiently powered randomized clinical trials to evaluate the comparative effectiveness of the cognitive and the fusion targeting technique in detecting csPCa. Thus, we are conducting the FOCUS-PC study to address this significant gap in knowledge. Methods: The study is designed as a pragmatic, parallel group, multicenter, non-inferiority randomized clinical trial comparing the diagnostic yield of fusion and cognitive biopsy in detecting csPCa. The fusion biopsy will serve as the reference standard for testing the inferiority of cognitive approach. The primary outcome measure is the difference in the detection rate of csPCa in the MRI-targeted biopsy cores between the fusion and the cognitive techniques. The csPCa is defined as grade group 2 or higher (presence of any Gleason pattern 4). The eligibility criteria are meant to be to be inclusive, reflective of real-world practice and in line with the pragmatic design of the study: • Undergo a prostate biopsy, either transrectal or transperineal, for detection of prostate cancer. • Pre-biopsy mp-MRI of prostate with at least 1 lesion classified as PIRADS • 3. • Largest dimension of the MRI-detected lesion • 2 cm. • Prostate-specific antigen level • 25 ng/mL and/or abnormal digital rectal examination. • Biopsy-naive or no previous negative prostate biopsy within 3 years. The sample size and statistical power analysis were conducted with baseline assumptions that were informed by the contemporary randomized clinical trials. These RCTs used a combination of Fus-Bx and Cog-Bx techniques and demonstrated that csPCa detection rates following MRI-targeted prostate biopsy were 50%-55%. In a systematic review of comparative studies, including three small RCTs (<100 patients), two reported similar csPCa rates while one favored Fus-Bx, whereas three other studies reported a 3-4% higher rate of csPCa detection using the Cog-Bx technique compared to Fus-Bx. The sample size was calculated with power set at 80% and one-sided significance level at 0.025. The expected csPCa detection rates for Fus-Bx and Cog- Bx were set at 52% and 55% respectively. The number of participants needed is 610 per group, with a dropout rate of 5%, 1281 participants will be enrolled in the study. Eligible men with MRI-detected lesions will be randomly assigned to the fusion or cognitive targeted biopsy approach. The biopsy may be conducted via transrectal or transperineal approach, based on the usual practice of the investigators, and the availability of the fusion platform. Both study arms must be conducted in the same setting i.e. clinic under local anesthesia or the operating room under sedation. The study will be conducted at 10 centers including urban areas to ensure representation of the population. Enrollment began in February 2025, with five other centers to begin enrollment in the next 2 months and the remaining centers enrolling by July 2025. The anticipated study completion date is June 2027.

Volume

213

Issue

5

First Page

e24

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