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

Not Applicable

Recruiting

• Conditions: Patients With Suspected Prostate Cancer
• Interventions: Procedure: Biopsy

• Registration Number: NCT05763355
• Lead Sponsor: Elsan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-10
• Study Start: 2023-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 596

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transrectal biopsy using KOELIS fusion system	Biopsy	Transrectal procedure will be performed with the patient in the left lateral position with a completely free-hand technique utilising the KOELIS fusion system.
Transperineal biopsy using KOELIS perine grid	Biopsy	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).

Primary Outcome Measures

Name	Time	Method
Comparison of the rate of occurrence of biopsy-induced infection in both groups	30 days after intervention	Biopsy-induced infection are defined as : * Positive post-biopsy urinary test result; * Clinical infection syndrome (T\>37.5°C fever); * Signs of urogenital infection (cystitis/prostatitis/orchi-epididymitis); * Hospitalization for hyperpyrexia; * Septic shock

Secondary Outcome Measures

Name	Time	Method
Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups	30 days after intervention
Comparison of the Room occupancy time in both groups	1 day
Comparison of the Percentage of underestimation of the stage of tumor development in both groups	3 months after intervention	Confrontation with the MRI result and the resected specimen of the radical prostatectomy
Comparison of the Procedure Time in both groups	1 day	Procedure time = Endorectal Ultrasound Probe Introduction Time - Probe Removal Time
Comparison of the percentage of positive biopsies on on anterior areas in both groups	30 days after intervention
Comparison of the rate of rectal bleeding in both groups	30 days after intervention
Comparison of the percentage of negative biopsies in both groups	30 days after intervention
Comparison of the Average Length of Stay in both groups	1 day
Assess the pain (tolerance) felt by the patient according to the biopsy method used	1 day	EVA pain scale at J0

Trial Locations

Locations (2)

Centre Médico-Chirurgical Les Cèdres; 🇫🇷 Brive-la-Gaillarde, France

Clinique St Augustin; 🇫🇷 Bordeaux, France