This study aimed to assess the medium-term oncologic outcomes of an active surveillance protocol, replacing confirmatory biopsy with serial multiparametric MRI (mpMRI).
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 mpMRI and template +/- targeted biopsy, then mpMRI at year 1 and 2 with a 3-year end of protocol biopsy. Biopsies during the 3-year protocol period were triggered by abnormalities on mpMRI and/or increases in PSA density (PSAD, >0.2ng/mL/cc).
The sensitivity, specificity, PPV, and NPV of mpMRI to detect progression to clinically significant prostate cancer was 57% (95% CI 39-74), 82% (95% CI 74-89), 50% (95% CI 38-62) and 86% (95% CI 81-90) respectively. Both mpMRI and PSAD were significant predictors for progression (mpMRI OR 6.20, 95% CI 2.72-14.16, p <0.001); (PSAD OR 6.19, 95% CI 2.14-17.92, p=0.001). Only 2.3% (4/172) of patients had false negative mpMRIs and high-risk pathologic features (pT3 or high-volume ISUP>2). After a median 69 months (Q1-Q3 56-79) follow-up of all patients in the cohort, freedom from BCR, metastasis and PCa-related death were 99.3%, 100% and 100% respectively.
Final analysis of the MRIAS trial indicates that there is minimal risk to omitting 1-year confirmatory biopsy during AS if baseline MR-targeted + saturation template biopsy was performed, however standardized 3-year systematic biopsy should be performed due to occasional MRI-invisible tumours.
The Journal of urology. 2022 Aug 10 [Epub ahead of print]
Paul Doan, Matthijs J Scheltema, Amer Amin, Ron Shnier, Bart Geboers, William Gondoputro, Daniel Moses, Pim J van Leeuwen, Anne Maree Haynes, Jayne Matthews, Phillip Brenner, Gordon O'Neill, Carlo Yuen, Warick Delprado, Phillip Stricker, James Thompson
St. Vincent's Prostate Cancer Centre, Department of Urology, Darlinghurst, Sydney, NSW, Australia., I-MED Radiology, Sydney, NSW, Australia., Spectrum Medical Imaging, Sydney, NSW Australia., Deparatment of Urology, Amsterdam University Medical Centers (location VUmc), Amsterdam, the Netherlands., Garvan Institute of Medical Research & The Kinghorn Cancer Centre, Darlinghurst, Sydney, NSW, Australia., Douglas Hanly Moir Pathology, Sydney, NSW, Australia.