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TransPERineal Fusion Biopsy Versus transrECTal (PERFECT)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsy
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center;
  • Patient with at least one PI-RADS 4-5 lesion on MRI;
  • Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized;
  • Patient with negative pre-biopsy antibacteriological urine examination ;
  • Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL;
  • Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study.

Exclusion Criteria:

  • Patient who has already had a prostate biopsy;
  • Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8
  • Patient with negative MRI or whose lesions have a PI-RADS score <4;
  • Patient with impassable rectal stenosis;
  • Patient with a dermatological disease preventing perineal access;
  • Patient with rectal amputation;
  • Patient presenting with a urinary tract infection;
  • Patient on anticoagulant treatment at an effective oral dose, not relayed;
  • Patient participating in another clinical trial, or in a period of exclusion from another clinical trial

Sites / Locations

  • Clinique La Croix Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transperineal biopsy

transrectal biopsy

Arm Description

The strategy evaluated is based on performing targeted and systematized prostate biopsies performed by the transperineal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.

The comparison strategy is based on performing targeted and systematized prostate biopsies performed by the transrectal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.

Outcomes

Primary Outcome Measures

Efficacy of the targeted biopsy in terms of detection of significant cancers.
Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2021
Last Updated
May 22, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05069584
Brief Title
TransPERineal Fusion Biopsy Versus transrECTal
Acronym
PERFECT
Official Title
Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
May 12, 2023 (Actual)
Study Completion Date
May 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.
Detailed Description
Interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transperineal biopsy
Arm Type
Experimental
Arm Description
The strategy evaluated is based on performing targeted and systematized prostate biopsies performed by the transperineal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.
Arm Title
transrectal biopsy
Arm Type
Active Comparator
Arm Description
The comparison strategy is based on performing targeted and systematized prostate biopsies performed by the transrectal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
patient must have a biopsy for his prostate cancer
Primary Outcome Measure Information:
Title
Efficacy of the targeted biopsy in terms of detection of significant cancers.
Description
Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.
Time Frame
Day 21

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center; Patient with at least one PI-RADS 4-5 lesion on MRI; Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized; Patient with negative pre-biopsy antibacteriological urine examination ; Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL; Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study. Exclusion Criteria: Patient who has already had a prostate biopsy; Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8 Patient with negative MRI or whose lesions have a PI-RADS score <4; Patient with impassable rectal stenosis; Patient with a dermatological disease preventing perineal access; Patient with rectal amputation; Patient presenting with a urinary tract infection; Patient on anticoagulant treatment at an effective oral dose, not relayed; Patient participating in another clinical trial, or in a period of exclusion from another clinical trial
Facility Information:
Facility Name
Clinique La Croix Sud
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TransPERineal Fusion Biopsy Versus transrECTal

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