The PRECISION study: Prostate evaluation for clinically important disease, sampling using image-guidance or not? (NCT02380027) [Meeting Abstract]
Kasivisvanathan, V; Rannikko, A; Borghi, M; Panebianco, V; Mynderse, L; Vaarala, M; Briganti, A; Budaus, L; Hellawell, G; Hindley, R; Roobol, M; Eggener, S; Ghei, M; Villers, A; Bladou, F; Villeirs, G; Virdi, J; Boxler, S; Robert, G; Singh, P; Venderink, W; Hadaschik, B; Ruffion, A; Hu, J; Margolis, D; Crouzet, S; Klotz, L; Taneja, S; Pinto, P; Gill, I; Allen, C; Giganti, F; Freeman, A; Morris, S; Punwani, S; Williams, N; Brew-Graves, C; Takwoingi, Y; Emberton, M; Moore, C
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 naive men. Patients & Methods: PRECISION was a randomised, non-inferiority trial, carried out in 25 centres in 11 coun-tries. 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
EMBASE:623153747
ISSN: 2051-4166
CID: 3211092
The institutional learning curve for MRI-US Fusion-Targeted Prostate Biopsy: Temporal improvements in cancer detection over four years
Meng, Xiaosong; Rosenkrantz, Andrew B; Huang, Richard; Deng, Fang Ming; Wysock, James S; Bjurlin, Marc; Huang, William C; Lepor, Herbert; Taneja, Samir S
PURPOSE/OBJECTIVE:While MRI-Ultrasound Fusion-targeted biopsy (MRF-TB) allows for improved detection of clinically significant prostate cancer (csPCa), concerning numbers of clinically significant disease are still missed. We hypothesize that a number of these are due to the learning curve associated with MRF-TB. We report results of repeat MRF-TB in men with continued suspicion for cancer and the institutional learning curve in detection of csPCa over time. MATERIALS AND METHODS/METHODS:Analysis of 1813 prostate biopsies in a prospectively acquired cohort of men presenting for prostate biopsy over a 4-year period. All men were offered pre-biopsy MRI and assigned a maximum Prostate Imaging - Reporting and Data System version 2 (PI-RADS) score. Biopsy outcomes of men with suspicious region of interest (ROI) were compared. The relationship between time and csPCa detection was analyzed. RESULTS:csPCa detection rate increased 26% over time in men with PI-RADS 4 and 5 (4/5) ROI. On repeat MRF-TB in men with continued suspicion for cancer, 53% of men with PI-RADS 4/5 ROI demonstrated clinically significant discordance from initial MRF-TB, compared to only 23% of men with PI-RADS 1/2 ROI. Significantly less csPCa were missed or under-graded in the most recent biopsies as compared to the earliest biopsies. CONCLUSION/CONCLUSIONS:High upgrade rates on repeat MRF-TB and increasing cancer detection rate over time demonstrate the significant learning curve associated with MRF-TB. Men with low risk or negative biopsies with persistent concerning ROI should be promptly re-biopsied. Improved targeting accuracy with operator experience can help decrease the number of missed csPCa.
PMID: 29886090
ISSN: 1527-3792
CID: 3155122