Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category

Juan Morote; Miriam Campistol; Marina Triquell; Anna Celma; Lucas Regis; Inés de Torres; Maria E Semidey; Richard Mast; Anna Santamaria; Jacques Planas; Enrique Trilla

doi:10.1016/j.euros.2021.12.009

Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category

Eur Urol Open Sci. 2022 Jan 23:37:38-44. doi: 10.1016/j.euros.2021.12.009. eCollection 2022 Mar.

Authors

Juan Morote^{1

2

3}, Miriam Campistol², Marina Triquell², Anna Celma^{1

2}, Lucas Regis^{1

2}, Inés de Torres^{2

4

5}, Maria E Semidey^{2

3

4}, Richard Mast³, Anna Santamaria², Jacques Planas^{1

2}, Enrique Trilla^{1

5}

Affiliations

¹ Department of Urology, Vall d'Hebron Hospital, Barcelona, Spain.
² Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.
³ Department of Radiology, Vall d'Hebron Hospital, Barcelona, Spain.
⁴ Department of Pathology, Vall d'Hebron Hospital, Barcelona, Spain.
⁵ Universitat Autònoma of Barcelona, Barcelona, Spain.

Abstract

Background: Prostate Imaging-Reporting and Data System (PI-RADS) category 3 is a challenging scenario for detection of clinically significant prostate cancer (csPCa) and some tools can improve the selection of appropriate candidates for prostate biopsy.

Objective: To assess the performance of the European Randomized Study of Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI) model, the new Proclarix test, and prostate-specific antigen density (PSAD) in selecting candidates for prostate biopsy among men in the PI-RADS 3 category.

Design setting and participants: We conducted a head-to-head prospective analysis of 567 men suspected of having PCa for whom guided and systematic biopsies were scheduled between January 2018 and March 2020 in a single academic institution. A PI-RADS v.2 category 3 lesion was identified in 169 men (29.8%).

Outcome measurement and statistical analysis: csPCa, insignificant PCa (iPCa), and unnecessary biopsy rates were analysed. csPCa was defined as grade group ≥2. Receiver operating characteristic (ROC) curves, decision curve analysis curves, and clinical utility curves were plotted.

Results and limitations: PCa was detected in 53/169 men (31.4%) with a PI-RADS 3 lesion, identified as csPCa in 25 (14.8%) and iPCa in 28 (16.6%). The area under the ROC curve for csPCa detection was 0.703 (95% confidence interval [CI] 0.621-0.768) for Proclarix, 0.657 (95% CI 0.547-0.766) for the ERSPC MRI model, and 0.612 (95% CI 0.497-0.727) for PSAD (p = 0.027). The threshold with the highest sensitivity was 10% for Proclarix, 1.5% for the ERSPC MRI model, and 0.07 ng/ml/cm³ for PSAD, which yielded sensitivity of 100%, 91%, and 84%, respectively. Some 21.3%, 26.2%, and 7.1% of biopsies would be avoided with Proclarix, PSAD, and the ERSPC MRI model, respectively. Proclarix showed a net benefit over PSAD and the ERSPC MRI model. Both Proclarix and PSAD reduced iPCa overdetection from 16.6% to 11.3%, while the ERSPC MRI model reduced iPCa overdetection to 15.4%.

Conclusions: Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model. Proclarix detected 100% of csPCa cases and would reduce prostate biopsies by 21.3% and iPCa overdetection by 5.3%.

Patient summary: We compared three methods and found that the Proclarix test can optimise the detection of clinically significant prostate cancer in men with a score of 3 on the Prostate Imaging-Reporting and Data System for magnetic resonance imaging scans.

Keywords: Clinically significant prostate cancer; European Randomized Study of Screening for Prostate Cancer predictive model; Multiparametric magnetic resonance imaging; Proclarix; Prostate-specific antigen density.