Abstract
RATIONALE AND OBJECTIVES: The study aims to propose an optimal workflow in patients with a PI-RADS 3 (PR-3) assessment category (AC) through determining the timing and type of pathology interrogation used for the detection of clinically significant prostate cancer (csPCa) in these men based upon a 5-year retrospective review in a large academic medical center. MATERIALS AND METHODS: This United States Health Insurance Probability and Accountability Act (HIPAA)-compliant, institutional review board-approved retrospective study included men without prior csPCa diagnosis who received PR-3 AC on magnetic resonance (MR) imaging (MRI). Subsequent incidence and time to csPCa diagnosis and number/type of prostate interventions was recorded. Categorical data were compared using Fisher's exact test and continuous data using ANOVA omnibus F-test. RESULTS: Our cohort of 3238 men identified 332 who received PR-3 as their highest AC on MRI, 240 (72.3%) of whom had pathology follow-up within 5 years. csPCa was detected in 76/240 (32%) and non-csPCa in 109/240 (45%) within 9.0 ± 10.6 months. Using a non-targeted trans-rectal ultrasound biopsy as the initial approach (n = 55), another diagnostic procedure was required to diagnose csPCa in 42/55 (76.4%) of men, compared with 3/21(14.3%) men with an initial MR targeted-biopsy approach (n = 21); (p < 0.0001). Those with csPCa had higher median serum prostate-specific antigen (PSA) and PSA density, and lower median prostate volume (p < 0.003) compared with non-csPCa/no PCa. CONCLUSION: Most patients with PR-3 AC underwent prostate pathology exams within 5 years, 32% of whom were found to have csPCa within 1 year of MRI, most often with a higher PSA density and a prior non-csPCa diagnosis. Addition of a targeted biopsy approach initially reduced the need for a second biopsy to reach a for csPCa diagnosis. Thus, a combination of systematic and targeted biopsy is advised in men with PR-3 and a co-existing abnormal PSA and PSA density.