Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients with suspected prostate cancer consequently underwent TRUS-guided, cognitive, fusion and transperineal template mapping biopsy

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).

consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)

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).

First step: the "unblinded" urologist №1 performed a fusion and transpeineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy. All specimens were obtained within a single procedure.

The "blinded" urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results

Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients

Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients

Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients

Ratio of cores with detected prostate cancer in relation to overall numbers of cores

Median length of core with prostate cancer in realtion to whole biopsy core

Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies

Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies

Prognostic factors of clinically significant and overall prostate cancer detection rate

Gleason score obtained within biopsy and the post-prostatectomy pathology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection	NCT05589558	Prostate Cancer Prostate Adenoc...	consequently pe...	18 Years -	I.M. Sechenov First Moscow State Medical University
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection	NCT05589558	Prostate Cancer Prostate Adenoc...	consequently pe...	18 Years -	I.M. Sechenov First Moscow State Medical University

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