Head-to-head Comparison of Transrectal Ultrasound-guided Prostate Biopsy Versus Multiparametric Prostate Resonance Imaging with Subsequent Magnetic Resonance-guided Biopsy in Biopsy-naïve Men with Elevated Prostate-specific Antigen: A Large Prospective Multicenter Clinical Study

• Published in: European urology 2019-04, Vol.75 (4), p.570-578
• Main Authors: van der Leest, Marloes, Cornel, Erik, Israël, Bas, Hendriks, Rianne, Padhani, Anwar R., Hoogenboom, Martijn, Zamecnik, Patrik, Bakker, Dirk, Setiasti, Anglita Yanti, Veltman, Jeroen, van den Hout, Huib, van der Lelij, Hans, van Oort, Inge, Klaver, Sjoerd, Debruyne, Frans, Sedelaar, Michiel, Hannink, Gerjon, Rovers, Maroeska, Hulsbergen-van de Kaa, Christina, Barentsz, Jelle O.
• Format: Article
• Language: English
• Subjects: Aged; Comparative Effectiveness Research; Humans; Image-Guided Biopsy - methods; Kallikreins - blood; Magnetic Resonance Imaging; Magnetic Resonance Imaging, Interventional; Magnetic resonance-guided biopsy; Male; Middle Aged; Multiparametric magnetic resonance imaging; Neoplasm Staging; Netherlands; Predictive Value of Tests; Prospective Studies; Prostate cancer; Prostate Imaging Reporting and Data System; Prostate-Specific Antigen - blood; Prostatic Neoplasms - blood; Prostatic Neoplasms - diagnostic imaging; Prostatic Neoplasms - pathology; Reproducibility of Results; Transrectal ultrasound-guided biopsy; Ultrasonography, Interventional; Up-Regulation
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2018.11.023

There is growing interest to implement multiparametric magnetic resonance imaging (mpMRI) and MR-guided biopsy (MRGB) for biopsy-naïve men with suspected prostate cancer. Primary objective was to compare and evaluate an MRI pathway and a transrectal ultrasound-guided biopsy (TRUSGB) pathway in biopsy-naïve men with prostate-specific antigen levels of ≥3ng/ml. A prospective, multicenter, powered, comparative effectiveness study included 626 biopsy-naïve patients (from February 2015 to February 2018). All patients underwent prebiopsy mpMRI followed by systematic TRUSGB. Men with suspicious lesions on mpMRI also underwent MRGB prior to TRUSGB. MRGB was performed using the in-bore approach. Clinically significant prostate cancer (csPCa) was defined as grade group ≥2 (Gleason score ≥3+4) in any core. The main secondary objectives were the number of men who could avoid biopsy after nonsuspicious mpMRI, the number of biopsy cores taken, and oncologic follow-up. Differences in proportions were tested using McNemar's test with adjusted Wald confidence intervals for differences of proportions with matched pairs. The MRI pathway detected csPCa in 159/626 (25%) patients and insignificant prostate cancer (insignPCa) in 88/626 patients (14%). TRUSGB detected csPCa in 146/626 patients (23%) and insignPCa in 155/626 patients (25%). Relative sensitivity of the MRI pathway versus the TRUSGB pathway was 1.09 for csPCa (p=0.17) and 0.57 for insignPCa (p