Comparing two methods of prostate biopsy for cancer diagnosis
Multicentric Comparative Prospective Study of the Benefits and Risks of Biopsy Prostate Using Transrectal or Transperineal Procedure for the Prostate Cancer Diagnostic.
This study is testing which of two prostate biopsy methods, one through the rectum and one through the skin, is safer and better at finding cancer for men who might have it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 596 (estimated) |
| Sex | Male |
| Sponsor | Elsan Academic / other |
| Locations | 2 sites (Bordeaux and 1 other locations) |
| Trial ID | NCT05763355 on ClinicalTrials.gov |
What this trial studies
This study compares the benefits and risks of two biopsy techniques for diagnosing prostate cancer: transrectal and transperineal. The transrectal method involves inserting a needle through the rectum, while the transperineal method uses a needle inserted through the skin, which may reduce infection risks and improve tumor detection. Patients with suspected prostate cancer will be evaluated to determine which method provides better outcomes. The study aims to provide clearer insights into the effectiveness and safety of these biopsy approaches.
Who should consider this trial
Good fit: Ideal candidates are patients with suspected prostate cancer who meet specific MRI staging or grading criteria.
Not a fit: Patients without suspected prostate cancer or those with other medical conditions that interfere with the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective biopsy techniques for diagnosing prostate cancer.
How similar studies have performed: While there is limited randomized comparison data available, the transperineal approach has shown promise in reducing complications in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 1 other locations
- Clinique St Augustin — Bordeaux, France (Recruiting)
- Centre Médico-Chirurgical Les Cèdres — Brive-la-Gaillarde, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Pierre-Thierry PIECHAUD, MD
- Email: pthpiechaud@hotmail.fr
- Phone: (0)6.09.71.58.67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.