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

Trial Title: 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

Condition: Patients With Suspected Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Transpérinéal
Transrectal
Biopsy
Prostate
Cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: 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.
Arm group label: Transperineal biopsy using KOELIS perine grid
Arm group label: Transrectal biopsy using KOELIS fusion system

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.

Criteria for 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

Gender: Male

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clinique St Augustin

Address:
City: Bordeaux
Zip: 33074
Country: France

Status: Recruiting

Contact:
Last name: Pierre-Thierry PIECHAUD, MD
Email: pthpiechaud@hotmail.fr

Investigator:
Last name: Pierre-Thierry PIECHAUD, MD
Email: Principal Investigator

Facility:
Name: Centre Médico-Chirurgical Les Cèdres

Address:
City: Brive-la-Gaillarde
Zip: 19100
Country: France

Status: Not yet recruiting

Contact:
Last name: Pascal BOURNEL, MD
Email: pascal.bournel@les-cedres.com

Start date: December 15, 2023

Completion date: December 2025

Lead sponsor:
Agency: Elsan
Agency class: Other

Source: Elsan

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05763355