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Outcomes of Serial MRI-Fusion Biopsy in Men with Low-Risk Prostate Cancer Managed with Active Surveillance.
Jamil S. Syed, MD, Walter Hsiang, BS, Kevin A. Nguyen, MS, Alfredo Suarez-Sarmiento, MD, Michael S. Leapman, MD, Preston C. Sprenkle, MD.
Yale Department of Urology, New Haven, CT, USA.

BACKGROUND: Although targeted multi-parametric MRI (mpMRI) - ultrasound (US) fusion biopsy has demonstrated improvements in diagnostic yield compared with standard systematic biopsy, the outcomes of repeated biopsy among men with clinical low risk prostate cancer (PCa) managed with active surveillance (AS) has not been clearly defined. METHODS: We queried a single institution prospectively collected database of patients undergoing mpMRI fusion biopsy to identify patients on AS with at least two fusion biopsies. AS inclusion criteria included any volume of Gleason (Gl) 3+3 PCa and a PSA<15. The primary study endpoint was the occurrence of Gl upgrading on subsequent biopsy. For patients with Gl upgrading, mpMRI changes were documented only if PI-RADS suspicion score data was available. The chi-square and independent samples t-test were used to compare categorical and continuous variables, respectively, and assess associations with biopsy upgrade. RESULTS: Between December 2013 and November 2016 there were 209 patients on AS who received a mpMRI/US fusion targeted biopsy. Of these, 20.5% (43/209) had at least two targeted biopsies. The average time between biopsies was 15 months. Initial clinical stage T1c disease was documented in 88% (38/43), while 12% (5/43) were clinical stage T2a. Median age was 62 years, (interquartile range (IQR), 59-66), median (IQR) PSA and PSA density was 4.7 (3.8-6.9) and 0.10 (0.06-0.15), respectively. There were 24% (10/43) of patients who had Gl ≥ 7 PCa detected on subsequent biopsy. Of these 80% (8/10) were upgraded to Gl 3+4 disease, while two patients had Gl ≥ 4+3 PCa. 50% (5/10) of patients were upgraded on both systematic and targeted biopsy, 30% (3/10) were upgraded with only systematic biopsy, while 20% (2/10) were upgraded with only targeted biopsy. For patients who had biopsy upgrade, PI-RADS data were available in 5 cases. Of these, 60% (3/5) were found to have associated mpMRI upgrading. Of patients with Gl upgrading, 50%, (5/10) went on to receive curative therapy. There were no significant associations between Gl upgrading and mpMRI change (p=0.7). Initial PSA density was higher for those who went on to have Gl upgrading (0.15 vs 0.10, p=0.04), however there were no differences in age, PSA, or time on AS (p> 0.05). CONCLUSIONS: In our initial experience with repeat mpMRI/US fusion targeted biopsy in the AS setting, we found that 24% of patients had Gl upgrading on subsequent biopsy. Of these patients, only 50% had concordant findings between targeted and systematic biopsy, with 20% and 30% detected with either targeted or systematic biopsy alone, respectively. MR-MRI upgrading did not predict Gl upgrading, and a clear role for systematic biopsy in AS remains. Although mpMRI has great potential in the AS setting, further data with larger sample size and utilizing a uniform method of lesion assessment will be useful.

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