Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Prostate Cancer Clinical Trial

Official title:

Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589558
• Other study ID #: Sechenov-four_biopsies
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: October 2022
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-a reductase inhibitors therapy within the last 6 months;

• extracapsular extension;

• prostate volume =80 cc;

• contraindications for mpMRI.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• consequently performed 4 biopsy methods (TRUS-guided biopsy, 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).

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & 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, Rouvière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall prostate cancer detection rate	Ratio of patients with preoperative Pi-RADS =3 with defined prostate cancer in relation to total number of patients	2 weeks after performed 4 biopsy methods
Secondary	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	2 weeks after performed 4 biopsy methods
Secondary	Positive biopsy cores' number	Ratio of cores with detected prostate cancer in relation to overall numbers of cores	2 weeks after performed 4 biopsy methods
Secondary	Maximum cancer core length	Median length of core with prostate cancer in realtion to whole biopsy core	2 weeks after performed 4 biopsy methods
Secondary	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	2 weeks after performed 4 biopsy methods
Secondary	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	2 weeks after performed 4 biopsy methods
Secondary	Predicting factors of PCa detection	Prognostic factors of clinically significant and overall prostate cancer detection rate	2 weeks after performed 4 biopsy methods
Secondary	Comparison of biopsies and post-prostatectomy pathological results	Gleason score obtained within biopsy and the post-prostatectomy pathology	2 weeks after radical prostatectomy