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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05589558
Other study ID # Sechenov-four_biopsies
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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