PERFECT: TransPERineal Fusion Biopsy Versus transrECTal

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05069584
Collaborator
(none)
270
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Biopsy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: transperineal biopsy

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.

Procedure: Biopsy
patient must have a biopsy for his prostate cancer

Active Comparator: transrectal biopsy

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.

Procedure: Biopsy
patient must have a biopsy for his prostate cancer

Outcome Measures

Primary Outcome Measures

  1. Efficacy of the targeted biopsy in terms of detection of significant cancers. [Day 21]

    Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05069584
Other Study ID Numbers:
  • 2021-A01793-38
First Posted:
Oct 6, 2021
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021