Comparing different surgical methods for prostate cancer treatment
Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
This study is testing which surgical method—robot-assisted laparoscopy, conventional laparoscopy, or laparotomy—works best for treating prostate cancer and how they affect urinary and erectile function after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Elsan Academic / other |
| Locations | 30 sites (Agen and 29 other locations) |
| Trial ID | NCT04638088 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of robot-assisted laparoscopy, conventional laparoscopy, and laparotomy in performing radical prostatectomy for prostate cancer. It aims to assess urinary and erectile function outcomes before and after surgery to determine the benefits of each surgical approach. The study addresses the lack of prior validation for robotic surgery in this context and seeks to provide reliable data to inform healthcare authorities and patients. By analyzing a large cohort of patients, the study hopes to clarify the real benefits of robotic surgery compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for a planned radical prostatectomy.
Not a fit: Patients who refuse consent or lack French Health Care Insurance coverage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective surgical approach for prostate cancer, potentially improving patient outcomes.
How similar studies have performed: Previous studies have indicated mixed results regarding robotic surgery's advantages, highlighting the need for this comprehensive evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient hospitalized for a planned radical prostatectomy Exclusion Criteria: * Consent refusal from the patient * Patients protected by law (Art.L 1121-5, 1121-6, 1121-8 du Code de la santé publique) * Absence of a French Health Care Insurance coverage
Where this trial is running
Agen and 29 other locations
- Clinique Esquirol Saint Hilaire — Agen, France (Recruiting)
- Clinique Rhône Durance — Avignon, France (Completed)
- Hôpital Privé La Châtaigneraie — Beaumont, France (Completed)
- Clinique St Vincent — Besançon, France (Completed)
- Polyclinique de Franche Comté — Besançon, France (Completed)
- Clinique de Saint Augustin — Bordeaux, France (Completed)
- Clinique Keraudren - CHPB — Brest, France (Recruiting)
- Centre Médico-Chirurgical Les Cèdres — Brive-la-Gaillarde, France (Recruiting)
- Polyclinique Médipôle Saint-Roch — Cabestany, France (Completed)
- Polyclinique du Parc — Caen, France (Completed)
- Polyclinique Montréal — Carcassonne, France (Recruiting)
- Pôle Santé République — Clermont-Ferrand, France (Recruiting)
- Hôpital Privé Saint-François — Désertines, France (Withdrawn)
- Clinique Cap-d'Or — La Seyne-sur-Mer, France (Completed)
- Pôle Santé Sud — Le Mans, France (Completed)
- Clinique Emailleurs-Colombier — Limoges, France (Recruiting)
- Polyclinique de Limoges — Limoges, France (Completed)
- Clinique Claude Bernard — Metz, France (Withdrawn)
- Polyclinique de Gentilly — Nancy, France (Completed)
- Clinique Saint-Augustin — Nantes, France (Completed)
- Polyclinique Grand Sud — Nîmes, France (Completed)
- Polyclinique Les Fleurs — Ollioules, France (Completed)
- Polyclinique de Poitiers — Poitiers, France (Recruiting)
- Clinique du Renaison — Roanne, France (Recruiting)
- Clinique Guillaume De Varye — Saint-Doulchard, France (Completed)
- Centre clinical — Soyaux, France (Completed)
- Clinique de l'Estrée — Stains, France (Completed)
- Clinique Ambroise Paré — Toulouse, France (Recruiting)
- Polyclinique Vauban — Valenciennes, France (Completed)
- Hôpital privé Océane — Vannes, France (Completed)
Study contacts
- Principal investigator: Pierre-Thierry PIECHAUD, MD — Elsan
- Study coordinator: Shahnaz KLOUCHE, MD
- Email: klouche@elsan.care
- Phone: 00331 58 56 41 71
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.