Comparative Analysis of PSA Density and an MRI-Based Predictive Model to Improve the Selection of Candidates for Prostate Biopsy

Abstract

This study is a head-to-head comparison between mPSAD and MRI-PMbdex. The MRI-PMbdex was created from 2432 men with suspected PCa; this cohort comprised the development and external validation cohorts of the Barcelona MRI predictive model. Pre-biopsy 3-Tesla multiparametric MRI (mpMRI) and 2 to 4-core transrectal ultrasound (TRUS)-guided biopsies for suspicious lesions and/or 12-core TRUS systematic biopsies were scheduled. Clinically significant PCa (csPCa), defined as Gleason-based Grade Group 2 or higher, was detected in 934 men (38.4%). The area under the curve was 0.893 (95% confidence interval [CI]: 0.880–0.906) for MRI-PMbdex and 0.764 (95% CI: 0.774–0.783) for mPSAD, with p < 0.001. MRI-PMbdex showed net benefit over biopsy in all men when the probability of csPCa was greater than 2%, while mPSAD did the same when the probability of csPCa was greater than 18%. Thresholds of 13.5% for MRI-PMbdex and 0.628 ng/mL2 for mPSAD had 95% sensitivity for csPCa and presented 51.1% specificity for MRI-PMbdex and 19.6% specificity for mPSAD, with p < 0.001. MRI-PMbdex exhibited net benefit over mPSAD in men with prostate imaging report and data system (PI-RADS) <4, while neither exhibited any benefit in men with PI-RADS 5. Hence, we can conclude that MRI-PMbdex is more accurate than mPSAD for the proper selection of candidates for prostate biopsy among men with suspected PCa, with the exception of men with a PI-RAD S 5 score, for whom neither tool exhibited clinical guidance to determine the need for biopsy.

Magnetic Resonance Imaging, Clinical, and Biopsy Findings in Suspected Prostate Cancer

“…A total of 72 studies including 36 366 patients with suspected csPCa who underwent prostate MRI and subsequent biopsy were included (Figure 1). Details of the included study and patient characteristics are summarized in Table 1 and eTables 3 to 5 in Supplement 1. Studies were published between 2016 and 2022.…”

“…None of the included studies enrolled patients with prior csPCa. Among the 72 included studies, 19 solely included patients with low to moderate risk of csPCa (ie, PI-RADS≤3 and/or transitional zone index lesion and/or total PSA <10 ng/mL), 1 study solely included high-risk patients with PI-RADS 4 or greater, and the remaining 52 studies included all suspected patients regardless of the prostate MRI results or clinical parameters . The most frequently used imaging was 3.0 T (92.6%) and multiparametric MRI (80.3%).…”

“…Eight studies (11%) were judged to have a moderate risk of bias . No potential source of bias was identified for the other 64 (89%) studies . Retrospective study design and concern regarding the selection domain (ie, studies only noted that patients with suspected csPCa were included rather than providing detailed inclusion and/or exclusion criteria) were the main sources of bias.…”

“…As such, ancillary clinical data have been proposed to complement MRI to minimize the number of unnecessary biopsies. This concept has been recently expanded by numerous studies, and several MRI-based risk models and strategies have been developed to guide decisions on prostate biopsy . However, it has been challenging to integrate the proposed approaches into clinical practice owing to considerable inconsistencies among them.…”

“…BMI (9 studies,13,17,19,24,25,31,39,49,79 3946 patients) 24.7 (24.2-30.8)Positive family history of PCa (16 studies,12,24,26,38,44,46,49,52,56,58,[62][63][64][72][73][74] 10 095 patients), %17 (1-35)Positive DRE (33 studies,10, 15, 17, 18, 21-23, 26, 31-33, 37, 38, 41, 42, 44-47, 51-53, 56, 58, 62-64, 72-74, 77, 78, 81 19 129 patients), %23 (7-68)Black race (5 studies,12,15,46,66,79 1880 patients), % 14 (1-29) Prior negative biopsy (58 studies, 10-13, 15, 17, 18, 21-26, 28, 29, 31, 33-35, 37-58, 60-67, 70-74, 76-79 31 177 patients), % 18 (0-100) Abbreviations: BMI, body mass index (measured as weight in kilograms divided by height in meters squared); csPCa, clinically significant prostate cancer; DRE, digital rectal examination; MRI, magnetic resonance imaging; PI-RADS, Prostate Imaging Reporting & Data System; PSA, prostate-specific antigen; PSAD, prostate-specific antigen density. SI conversion factor: To convert PSA levels to μg/L, multiply by 1.0. a Specified per row.…”