NCT05763355

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 596 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2023-03-10
• Last updated: 2024-02-28

Locations

2 sites across 1 country: France