The aim of this study is to compare clinically significant prostate cancer detection rate by the 4 biopsy methods: TRUS-guided, cognitive, fusion and transperineal template mapping biopsy. It is recommended to combine MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) biopsy for high yield of prostate cancer diagnosis. Nevertheless, it remains unclear which biopsy combination is more precise for prostate cancer detection.
Taking into consideration the variety of prostate biopsy methods (TRUS-guided, cognitive, fusion and transperineal template mapping biopsy), the issue of indications for each of them remains unresolved. Current EAU guidelines recommend combining MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) one for high yield of prostate cancer diagnosis. Nevertheless, it also remains unclear which biopsy combination is more precise for prostate cancer detection. This is a prospective single-arm study. All patients underwent prostate TRUS examination and mpMRI. Suspicious lesion found on MRI were classified with the Pi-RADS v2.1. First step: the "unblinded" urologist №1 performed a fusion and transperineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy. Objectives of the study: to determine clinically significant prostate cancer detection rate, overall cancer detection rate, clinically insignificant prostate cancer detection rate, sampling efficiency (positive biopsy cores' number, maximum cancer core length (MCCL)). Results were calculated for each biopsy method separately and for combinations of TRUS-guided and cognitive biopsy (combination №1) and fusion and transperineal template mapping biopsy (combination №2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
102
TRUS-guided biopsy - extensive number of biopsies taken transrectally involving peripheral and transitional zones (8-12 cores); cognitive biopsy - targeted biopsy with MRI information and TRUS guidance but without fusion technology (2-4 cores); fusion biopsy - targeted biopsy with MRI information using MRI/TRUS fusion technology (2-4 core); transperineal template mapping biopsy - systematic transperineal TRUS-guided biopsy with special template use to aid accurate placement of biopsy needles (more than 20 cores).
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
Clinically significant prostate cancer detection rate
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients
Time frame: 2 weeks after performed 4 biopsy methods
Overall prostate cancer detection rate
Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients
Time frame: 2 weeks after performed 4 biopsy methods
Clinically insignificant prostate cancer detection rate
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients
Time frame: 2 weeks after performed 4 biopsy methods
Positive biopsy cores' number
Ratio of cores with detected prostate cancer in relation to overall numbers of cores
Time frame: 2 weeks after performed 4 biopsy methods
Maximum cancer core length
Median length of core with prostate cancer in realtion to whole biopsy core
Time frame: 2 weeks after performed 4 biopsy methods
Number of missed clinically significant prostate cancer
Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies
Time frame: 2 weeks after performed 4 biopsy methods
Added value of prostate cancer
Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies
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Time frame: 2 weeks after performed 4 biopsy methods
Predicting factors of PCa detection
Prognostic factors of clinically significant and overall prostate cancer detection rate
Time frame: 2 weeks after performed 4 biopsy methods
Comparison of biopsies and post-prostatectomy pathological results
Gleason score obtained within biopsy and the post-prostatectomy pathology
Time frame: 2 weeks after radical prostatectomy