A non‐inferiority comparative analysis of micro‐ultrasonography and MRI‐targeted biopsy in men at risk of prostate cancer

Abstract

To compare the efficacy of multiparametric magnetic resonance imaging (mpMRI)-directed and micro-ultrasonography (micro-US)-directed biopsy for detecting clinically significant (Grade Group >1) prostate cancer (csPCa). Materials and MethodsA total of 203 patients were prospectively enrolled at three institutions across Germany and Austria in the period from January 2019 to December 2019. During each biopsy, the urologist was blinded to the mpMRI report until after the micro-US targets had been assessed. After unblinding, targets were then sampled using software-assisted fusion, followed by systematic samples. The primary outcome measure was non-inferiority of micro-US to detect csPCa, with a detection ratio of at least 80% that of mpMRI. ResultsA total of 79 csPCa cases were detected overall (39%). Micro-US-targeted biopsy detected 58/79 cases (73%), while mpMRItargeted biopsy detected 60/79 (76%) and non-targeted (completion sampling) samples detected 45/79 cases (57%). mpMRItargeted samples alone detected 7/79 (9%) csPCa cases which were missed by micro-US-targeted and non-targeted samples. Three of these seven were anterior lesions with 2/7 in the transition zone. Micro-US-targeted samples alone detected 5/79 (6%) and completion sampling alone detected 4/79 cases (5%). Micro-US was non-inferior to mpMRI and detected 97% of the csPCa cases detected by mpMRI-targeted biopsy (95% CI 80-116%; P = 0.023). ConclusionsThis is the first multicentre prospective study comparing micro-US-targeted biopsy with mpMRI-targeted biopsy. The study provides further evidence that micro-US can reliably detect cancer lesions and suggests that micro-US biopsy might be as effective as mpMRI for detection of csPCA. This result has significant implications for increasing accessibility, reducing costs and expediting diagnosis.

Micro-ultrasound-guided biopsies versus systematic biopsies in the detection of prostate cancer: a systematic review and meta-analysis

“…Regarding the diagnostic accuracy of mUS, sensitivity, specificity, positive predictive value and negative predictive value for the detection of csPCa at the patient level ranged from 65-100%, 15-72%, 19-66% and 71-100% respectively (8,(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27).…”

“…Five studies provided raw data on the comparator arm (SB) and were included in the meta-analysis (8,14,(20)(21)(22).…”

“…Five studies compared mUS to SB in the clinical context of a suspicion of PCa (based on elevated PSA values and/or suspicious digital rectal examination), with SB raw data available (8,14,(20)(21)(22).…”

“…All studies but one focused on demonstrating either the non-inferiority of mUS to detect csPCa, compared to mpMRI, or the added value of mUS to the mpMRI pathway (8,(20)(21)(22). Abouassaly et al aimed at evaluating the added value of mUS over SB.…”

“…In the quantitative analysis of men with GGG ≥ 2 PCa, we included the 5 studies providing raw data on SB comprising 670 participants receiving mUS-guided biopsies, followed by MRI-TB (but for 48 patients) ( 14), followed by SB (8,14,(20)(21)(22). Overall, PCa was found in 56-71% of men, with 31.3-49% having csPCa defined as GGG ≥ 2, and 14.9-32.7% when defined as GGG ≥ 3 (14,21).…”