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Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, fusion biopsy, cognitive biopsy, transrectal ultrasound biopsy, transperineal template mapping biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Urology and Reproductive Health, Sechenov University.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspected prostate cancer underwent 4 biopsy methods

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall prostate cancer detection rate
Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients
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
Positive biopsy cores' number
Ratio of cores with detected prostate cancer in relation to overall numbers of cores
Maximum cancer core length
Median length of core with prostate cancer in realtion to whole biopsy core
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
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
Predicting factors of PCa detection
Prognostic factors of clinically significant and overall prostate cancer detection rate
Comparison of biopsies and post-prostatectomy pathological results
Gleason score obtained within biopsy and the post-prostatectomy pathology

Full Information

First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05589558
Brief Title
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
Official Title
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma
Keywords
prostate cancer, fusion biopsy, cognitive biopsy, transrectal ultrasound biopsy, transperineal template mapping biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
The "blinded" urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with suspected prostate cancer underwent 4 biopsy methods
Arm Type
Experimental
Arm Description
Patients with suspected prostate cancer consequently underwent TRUS-guided, cognitive, fusion and transperineal template mapping biopsy
Intervention Type
Procedure
Intervention Name(s)
consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinically significant prostate cancer detection rate
Description
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients
Time Frame
2 weeks after performed 4 biopsy methods
Secondary Outcome Measure Information:
Title
Overall prostate cancer detection rate
Description
Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients
Time Frame
2 weeks after performed 4 biopsy methods
Title
Clinically insignificant prostate cancer detection rate
Description
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients
Time Frame
2 weeks after performed 4 biopsy methods
Title
Positive biopsy cores' number
Description
Ratio of cores with detected prostate cancer in relation to overall numbers of cores
Time Frame
2 weeks after performed 4 biopsy methods
Title
Maximum cancer core length
Description
Median length of core with prostate cancer in realtion to whole biopsy core
Time Frame
2 weeks after performed 4 biopsy methods
Title
Number of missed clinically significant prostate cancer
Description
Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies
Time Frame
2 weeks after performed 4 biopsy methods
Title
Added value of prostate cancer
Description
Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies
Time Frame
2 weeks after performed 4 biopsy methods
Title
Predicting factors of PCa detection
Description
Prognostic factors of clinically significant and overall prostate cancer detection rate
Time Frame
2 weeks after performed 4 biopsy methods
Title
Comparison of biopsies and post-prostatectomy pathological results
Description
Gleason score obtained within biopsy and the post-prostatectomy pathology
Time Frame
2 weeks after radical prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
33172724
Citation
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.
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Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

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