Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Not Applicable

Completed

• Conditions: Prostate Cancer; Prostate Adenocarcinoma
• Interventions: Procedure: consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)

• Registration Number: NCT05589558
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-02-25
• Study Completion: 2022-02-25
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Last Update Submitted: 2022-10-18
• Study First Posted: 2022-10-21
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

Inclusion Criteria

• PSA >2 ng/mL, and/or positive digital rectal examination (DRE), and/or suspicious lesion on TRUS
• Pi-RADSv2.1 ≥3 score

Exclusion Criteria

• previously diagnosed PCa;
• acute prostatitis within the last 3 months;
• 5-α reductase inhibitors therapy within the last 6 months;
• extracapsular extension;
• prostate volume ≥80 cc;
• contraindications for mpMRI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with suspected prostate cancer underwent 4 biopsy methods	consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)	Patients with suspected prostate cancer consequently underwent TRUS-guided, cognitive, fusion and transperineal template mapping biopsy

Primary Outcome Measures

Name	Time	Method
Clinically significant prostate cancer detection rate	2 weeks after performed 4 biopsy methods	Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients

Secondary Outcome Measures

Name	Time	Method
Predicting factors of PCa detection	2 weeks after performed 4 biopsy methods	Prognostic factors of clinically significant and overall prostate cancer detection rate
Positive biopsy cores' number	2 weeks after performed 4 biopsy methods	Ratio of cores with detected prostate cancer in relation to overall numbers of cores
Maximum cancer core length	2 weeks after performed 4 biopsy methods	Median length of core with prostate cancer in realtion to whole biopsy core
Number of missed clinically significant prostate cancer	2 weeks after performed 4 biopsy methods	Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies
Comparison of biopsies and post-prostatectomy pathological results	2 weeks after radical prostatectomy	Gleason score obtained within biopsy and the post-prostatectomy pathology
Overall prostate cancer detection rate	2 weeks after performed 4 biopsy methods	Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients
Added value of prostate cancer	2 weeks after performed 4 biopsy methods	Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies
Clinically insignificant prostate cancer detection rate	2 weeks after performed 4 biopsy methods	Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients

Trial Locations

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.; 🇷🇺 Moscow, Russian Federation