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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

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

‣ MRI Staging: T2 or T3a,

⁃ MRI Grading: Pirads greater than or equal to 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,

Locations
Other Locations
France
Clinique St Augustin
RECRUITING
Bordeaux
Centre Médico-Chirurgical Les Cèdres
NOT_YET_RECRUITING
Brive-la-gaillarde
Contact Information
Primary
Pierre-Thierry PIECHAUD, MD
pthpiechaud@hotmail.fr
(0)6.09.71.58.67
Backup
Charlène PY, CRA
charlene.py@elsan.care
(0)7.64.51.03.73
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 596
Treatments
Other: 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.
Other: 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).
Related Therapeutic Areas
Sponsors
Leads: Elsan

This content was sourced from clinicaltrials.gov