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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients With Suspected Prostate Cancer

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, 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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transrectal biopsy using KOELIS fusion system<br>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<br>* 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.<br>|
| Other: Transperineal biopsy using KOELIS perine grid<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Confrontation with the MRI result and the resected specimen of the radical prostatectomy | 3 months after intervention | 
| Assess the pain (tolerance) felt by the patient according to the biopsy method used | EVA pain scale at J0 | 1 day | 
| Comparison of the Room occupancy time in both groups |  | 1 day | 
| Comparison of the Procedure Time in both groups | Procedure time = Endorectal Ultrasound Probe Introduction Time - Probe Removal Time | 1 day | 
| Comparison of the Average Length of Stay in both groups |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transpérinéal, Transrectal, Biopsy, Prostate, Cancer