NCT05763355Completed
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 11 Jan 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- Elsan
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT05763355
What you commit to
- Study type: Interventional
- Participants enrolled: 101
- From 15 Dec 2023 to the primary completion date, 7 Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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,
Other
- 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
Who the study is looking for
- 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,
Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique St Augustin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Clinical Coordinator of this site? Confirm its status | Soyaux | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.