Clinical trial Recruiting at 7 sites Interventional Ages 18 and up Men only

Comparing outpatient and inpatient robotic prostate surgery outcomes

Official title: Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

Run by Elsan · NCT06822452 · Data updated 2026-11-12

This study is testing if having robotic prostate surgery as an outpatient is just as safe as having it in the hospital, while also checking how it affects recovery and quality of life for men after the procedure.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment510 (estimated)
SponsorElsan
Academic / other
Locations12 sites (Avignon and 11 other locations)
StatusRecruiting
StartedDecember 30, 2024
Main results expectedJanuary 7, 2027
Study endsApril 30, 2030
Registry record updatedJuly 8, 2025
Trial IDNCT06822452 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are males aged 18 and over diagnosed with prostate cancer who are eligible for outpatient radical prostatectomy.

Probably not a fit

Patients who require inpatient management due to severe comorbidities or complications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate whether outpatient robotic-assisted radical prostatectomy is as safe as inpatient procedures regarding early post-operative complications. Participants will undergo the surgery and will be monitored through follow-up visits at 45 days, 6 months, and annually for up to 5 years. They will also complete surveys about their urinary and erectile functions, stress, anxiety, satisfaction, and quality of life for the first 6 months post-surgery. Additionally, participants will maintain a diary to document their care-related procedures and treatments.

Why it matters

Potential benefit: If successful, this study could provide a safer and more convenient outpatient option for patients undergoing prostate cancer surgery.

How similar studies have gone: Other studies have shown promising results for outpatient surgical approaches, suggesting that this method may be viable and effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male, aged 18 and over
* Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)
* Patient eligible for outpatient treatment :

  1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
  2. The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)
  3. The patient has access to telephone communication facilities.
  4. The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.
  5. The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.
* Participant affiliated to or benefiting from a social security scheme
* The participant has been informed and has given his/her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
* Patient participating in ongoing research or in a period of exclusion at the time of inclusion
* Refusal or inability to comply with the study protocol for any reason whatsoever
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Where it's running

  • Clinique St Vincent
    Besançon, France
    Recruiting
  • Clinique St Augustin
    Bordeaux, France
    Recruiting
  • Polyclinique Médipôle St-Roch
    Cabestany, France
    Recruiting
  • Pole Sante Sud-CMCM
    Le Mans, France
    Recruiting
  • Polyclinique Les Fleurs
    Ollioules, France
    Recruiting
  • Clinique Belledonne
    Saint-Martin-d'Hères, France
    Recruiting
Show 6 more locations
  • Hôpital Privé Océane
    Vannes, France
    Recruiting
  • Clinique Rhône Durance
    Avignon, France
    Not yet recruiting
  • Polyclinique du Parc
    Caen, France
    Not yet recruiting
  • Hôpital Privé Nancy Lorraine
    Nancy, France
    Not yet recruiting
  • Polyclinique Santé Atlantique
    Saint-Herblain, France
    Not yet recruiting
  • Centre clinical
    Soyaux, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.