An interventional study of Biopsy in Patients With Suspected Prostate Cancer, sponsored by Elsan. Completed at 2 sites in France. Open to male participants. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Elsan · Not applicable, Interventional, and Diagnostic
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 101 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Patients with suspected prostate cancer with at least one of the following criteria met :
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
Exclusion Criteria:
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 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
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.
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
Time frame: 30 days after intervention
Comparison of the rate of rectal bleeding in both groups
Time frame: 30 days after intervention
Comparison of the rate of urethral bleeding (hematuria and urethrorrhagia) in both groups
Time frame: 30 days after intervention
Comparison of the percentage of negative biopsies in both groups
Time frame: 30 days after intervention
Comparison of the percentage of positive biopsies on on anterior areas in both groups
Time frame: 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
Time frame: 3 months after intervention
Assess the pain (tolerance) felt by the patient according to the biopsy method used
EVA pain scale at J0
Time frame: 1 day
Comparison of the Room occupancy time in both groups
Time frame: 1 day
Comparison of the Procedure Time in both groups
Procedure time = Endorectal Ultrasound Probe Introduction Time - Probe Removal Time
Time frame: 1 day
Comparison of the Average Length of Stay in both groups
Time frame: 1 day
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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