Final Analysis of the Magnetic Resonance Imaging in Active Surveillance Trial

• Published in: The Journal of urology Vol. 208; no. 5; pp. 1028 - 1036
• Main Authors: Doan, Paul, Scheltema, Matthijs J., Amin, Amer, Shnier, Ron, Geboers, Bart, Gondoputro, William, Moses, Daniel, van Leeuwen, Pim J., Haynes, Anne Maree, Matthews, Jayne, Brenner, Phillip, O'Neill, Gordon, Yuen, Carlo, Delprado, Warick, Stricker, Phillip, Thompson, James
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Wolters Kluwer 01.11.2022
• Subjects: magnetic resonance imaging; prostate; neoplasms; watchful waiting
• ISSN: 0022-5347; 1527-3792; 1527-3792
• DOI: 10.1097/JU.0000000000002885

Purpose:This study aimed to assess the medium-term oncologic outcomes of an active surveillance protocol, replacing confirmatory biopsy with serial multiparametric magnetic resonance imaging.Materials and Methods:A total of 172 men were enrolled in this single-arm prospective trial. Men with prostate cancer (Gleason 3+3=6 or Gleason 3+4=7 with ≤10% Gleason pattern 4 overall and <2 cores Gleason pattern 4) eligible for surveillance were included in the study. Men underwent baseline multiparametric magnetic resonance imaging and template ± targeted biopsy, then multiparametric magnetic resonance imaging at years 1 and 2 with a 3-year end-of-protocol biopsy. Biopsies during the 3-year protocol period were triggered by abnormalities on multiparametric magnetic resonance imaging and/or increases in prostate specific antigen density (>0.2 ng/ml/cc).Results:The sensitivity, specificity, positive predictive value, and negative predictive value of multiparametric magnetic resonance imaging to detect progression to clinically significant prostate cancer were 57% (95% CI 39%-74%), 82% (95% CI 74%-89%), 50% (95% CI 38%-62%), and 86% (95% CI 81%-90%), respectively. Both multiparametric magnetic resonance imaging and prostate specific antigen density were significant predictors for progression (multiparametric magnetic resonance imaging OR 6.20, 95% CI 2.72-14.16, P < .001; prostate specific antigen density OR 6.19, 95% CI 2.14-17.92, P = .001). Only 2.3% (4/172) of patients had false-negative multiparametric magnetic resonance imaging and high-risk pathological features (pT3 or high-volume International Society of Urological Pathology >2). After a median 69 months (Q1-Q3 56-79) follow-up of all patients in the cohort, freedom from biochemical recurrence, metastasis, and prostate cancer-related death were 99.3%, 100%, and 100%, respectively.Conclusions:Final analysis of the Magnetic Resonance Imaging in Active Surveillance trial indicates that there is minimal risk to omitting 1-year confirmatory biopsy during active surveillance if baseline magnetic resonance-targeted + saturation template biopsy was performed; however, standardized 3-year systematic biopsy should be performed due to occasional magnetic resonance imaging-invisible tumors.