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

NCT05763355 | Completed

• 1 other identifier: 2021-A02436-35
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

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

Keywords

Transpérinéal; Transrectal; Biopsy; Prostate; Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of the rate of occurrence of biopsy-induced infection in both groups

  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

  30 days after intervention

Secondary Outcomes (9)

• Comparison of the rate of rectal bleeding in both groups

  30 days after intervention

• Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups

  30 days after intervention

• Comparison of the percentage of negative biopsies in both groups

  30 days after intervention

• Comparison of the percentage of positive biopsies on on anterior areas in both groups

  30 days after intervention

• Comparison of the Percentage of underestimation of the stage of tumor development in both groups

  3 months after intervention

Study Arms (2)

Transrectal biopsy using KOELIS fusion system

OTHER

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

Procedure: Biopsy

Transperineal biopsy using KOELIS perine grid

OTHER

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).

Procedure: Biopsy

Interventions

Biopsy 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; Transrectal biopsy using KOELIS fusion system

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (2)

Clinique St Augustin

Bordeaux, France, 33074, France

Location

Centre Clinical

Soyaux, 16800, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: March 10, 2023
• Study Start: December 15, 2023
• Primary Completion: July 7, 2025
• Study Completion: September 2, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (2)