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JU INSIGHT: Final Analysis of the Magnetic Resonance Imaging in Active Surveillance Trial

By: Paul Doan, MD, MS; Matthijs J. Scheltema, MD, PhD; Amer Amin, MD, MS; Ron Shnier, MD; Bart Geboers, MD, PhD; William Gondoputro, MD, MS; Daniel Moses, BSc, MD, MEngSc, PhD; Pim J. van Leeuwen, MD, PhD; Anne Maree Haynes, BSc; Jayne Matthews, BSc; Phillip Brenner, MD; Gordon O’Neill, MD; Carlo Yuen, MD; Warick Delprado, MD; Phillip Stricker, MD; James Thompson, BSc, MD, PhD | Posted on: 01 Nov 2022

Doan P, Scheltema MJ, Amin A, et al. Final analysis of the Magnetic Resonance Imaging in Active Surveillance trial. J Urol. 2022;208(5):1028-1036.

Study Need and Importance

Current active surveillance (AS) protocols involve the use of regular PSA tests, digital rectal examinations, and repeat biopsy to detect progression in prostate cancer (PCa) requiring definitive management. Repeat biopsy exposes patients to psychological distress and morbidity. There is limited prospective evidence regarding the diagnostic utility of multiparametric (mp) MRI in AS cohorts. mpMRI may improve detection of cancer progression and allow decreased frequency of biopsy in AS patients.

What We Found

The sensitivity, specificity, positive predictive value, and negative predictive value of mpMRI to detect progression to clinically significant PCa were 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 PSA density were significant predictors for progression. The Figure illustrates risk of clinically significant cancer at 3 years separated by mpMRI result. Only 2.3% (4/172) of patients had false-negative mpMRIs and high-risk pathological features (pT3 or high-volume International Society of Urological Pathology grade group >2). After a median of 69 months of follow-up, freedom from biochemical recurrence, metastasis, and PCa-related death were 99.3%, 100%, and 100%, respectively.

Figure. A, Risk of significant cancer at 3 years for Prostate Imaging-Reporting and Data System® (PI-RADS®) 2/stable PI-RADS 3 lesion. B, Risk of significant cancer at 3 years for new PI-RADS 3 lesion. C, Risk of significant cancer at 3 years for persistent PI-RADS 4/5 lesion. D, Risk of significant cancer at 3 years for new PI-RADS 4/5 lesion.

Limitations

The study is limited by design as it is a single-arm study. At time of study design PRECISE criteria had not been published and MRI progression was defined via expert consensus. The study employed the use of saturation template biopsy, which may reduce relevance to centers which employ limited 10- to 12-core transrectal ultrasound-guided biopsy.

Interpretation for Patient Care

Final analysis of the Magnetic Resonance Imaging in Active Surveillance trial indicates that 1-year confirmatory biopsy may be omitted with minimal risk to AS patients where magnetic resonance–targeted + saturation template biopsy was performed at baseline. mpMRI and PSA density were strong predictors of progression and can reduce frequency of biopsy in AS patients without significant impact on oncologic outcomes. However, standardized 3-year systematic biopsy should be performed regardless of mpMRI and PSA due to occasional MRI-invisible tumors.

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