Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

NCT05589558 | Completed

• 1 other identifier: Sechenov-four_biopsies
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

prostate cancer; fusion biopsy; cognitive biopsy; transrectal ultrasound biopsy; transperineal template mapping biopsy

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks after performed 4 biopsy methods

Secondary Outcomes (8)

• Overall prostate cancer detection rate

  2 weeks after performed 4 biopsy methods

• Clinically insignificant prostate cancer detection rate

  2 weeks after performed 4 biopsy methods

• Positive biopsy cores' number

  2 weeks after performed 4 biopsy methods

• Maximum cancer core length

  2 weeks after performed 4 biopsy methods

• Number of missed clinically significant prostate cancer

  2 weeks after performed 4 biopsy methods

Study Arms (1)

Patients with suspected prostate cancer underwent 4 biopsy methods

EXPERIMENTAL

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

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

Interventions

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

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).

Patients with suspected prostate cancer underwent 4 biopsy methods

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

Location

Related Publications (1)

• Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.

  PMID: 33172724 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The "blinded" urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: October 1, 2020
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

RU (1)