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

Patients With Suspected Prostate Cancer Clinical Trial

— BIOPROSTABORD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763355
• Other study ID #: 2021-A02436-35
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: Pierre-Thierry PIECHAUD, MD
• Phone: (0)6.09.71.58.67
• Email: pthpiechaud[@]hotmail.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 596
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Patients With Suspected Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Clinique St Augustin	Bordeaux
France	Centre Médico-Chirurgical Les Cèdres	Brive-la-Gaillarde

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

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