Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic

NCT ID: NCT05763355

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-12-31

Brief Summary

The performance of prostatic biopsies is an essential element to confirm the diagnosis of prostate cancer and to specify the characteristics of the tumor in terms of stage and grade.

The first route of prostatic biopsies is mainly transrectal with passage of a needle introduced into the guide fixed on the endorectal ultrasound probe. There is another possible access route, transperineal, with prostatic puncture by a needle introduced transcutaneously, guided by an endorectal ultrasound image. The first transperineal route would offer the first benefit for the patient, to reduce the infectious risk inherent in the endorectal way. It would also reduce the risk of rectal bleeding.

In addition, the transperineal pathway appears to be able to improve the detection threshold of prostatic tumours located on the anterior part of the gland due to the angle of penetration of the needle and its more anterior positioning relative to the prostate.

There is currently no randomized comparison study of the transperineal versus transrectal procedure on infectious risk. The aim of the project is to enable this comparative study, within our institution where experienced urologist surgeons practice.

Conditions

Patients With Suspected Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transrectal biopsy using KOELIS fusion system

Transrectal procedure will be performed with the patient in the left lateral position with a completely free-hand technique utilising the KOELIS fusion system.

Group Type: OTHER

Biopsy

Intervention Type: PROCEDURE

Biopsies will be performed under local anaesthesia. In all patients with a suspicious lesion (PIRADSv2.1 3-5) noted on the mp-MRI, the software-based image fusion biopsies will be obtained collecting 3 to 5 cores per target area according to its volume, 10-12 systematic cores of the remaining areas of the prostate will be collected from sectors specified in the PIRADSv2.1 prostate map.

Transperineal biopsy using KOELIS perine grid

Transperineal biopsy will be performed in the lithotomy position. KOELIS "Perine Grid" needle guidance device and "Steady Pro" free-hand probe arm will be utilised (free-hand assisted technique).

Group Type: OTHER

Biopsy

Intervention Type: PROCEDURE

Biopsies will be performed under local anaesthesia. In all patients with a suspicious lesion (PIRADSv2.1 3-5) noted on the mp-MRI, the software-based image fusion biopsies will be obtained collecting 3 to 5 cores per target area according to its volume, 10-12 systematic cores of the remaining areas of the prostate will be collected from sectors specified in the PIRADSv2.1 prostate map.

Interventions

Biopsy

Biopsies will be performed under local anaesthesia. In all patients with a suspicious lesion (PIRADSv2.1 3-5) noted on the mp-MRI, the software-based image fusion biopsies will be obtained collecting 3 to 5 cores per target area according to its volume, 10-12 systematic cores of the remaining areas of the prostate will be collected from sectors specified in the PIRADSv2.1 prostate map.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with suspected prostate cancer with at least one of the following criteria met :

1. MRI Staging: T2 or T3a,

2. MRI Grading: Pirads greater than or equal to 3

3. MRI tumor volume greater than or equal to 0.5 cm3

e.Patient without tumor lesion detected by prostate MRI less than 3 months old with PSA > 4 ng/ml, or an observed suspicious induration to the rectal exam

• Voluntarily signed and dated written informed consents prior to any study specific procedure,

Exclusion Criteria

• Other medical conditions may interfere with the conduct of the study and, in the judgment of the investigator, would make the patient inappropriate for entry into this study,
• Individuals deprived of liberty or placed under legal guardianship,
• Unwillingness or inability to comply with the study protocol for any reason.
• Patients without a health insurance

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique St Augustin

Bordeaux, , France

Site Status: RECRUITING

Centre Médico-Chirurgical Les Cèdres

Brive-la-Gaillarde, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Pierre-Thierry PIECHAUD, MD

Role: CONTACT

pthpiechaud@hotmail.fr

(0)6.09.71.58.67 ext. +33

Charlène PY, CRA

Role: CONTACT

charlene.py@elsan.care

(0)7.64.51.03.73 ext. +33

Facility Contacts

Pierre-Thierry PIECHAUD, MD

Role: primary

pthpiechaud@hotmail.fr

Pascal BOURNEL, MD

Role: primary

pascal.bournel@les-cedres.com

Other Identifiers

2021-A02436-35

Identifier Type: -

Identifier Source: org_study_id