Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure. (PROSTAMBU)

The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post-operative complications.

Researchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure.

Participants will:

• Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests.
• Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months
• Keep a diary to record procedures and treatments related to the care provided

Study Overview

• Status: Recruiting
• Conditions: Outpatient Surgery; Ambulatory Care; Prostate Cancer Surgery
• Intervention / Treatment: Procedure: radical prostatectomy

• Study Type: Interventional
• Enrollment (Estimated): 510
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlène PY, Eng; Phone Number: +33556003048; Email: charlene.py@elsan.care

Study Locations

• France
  • Avignon, France, 84000
    • Not yet recruiting
    • Clinique Rhône Durance
    • Contact: Christophe CLEMENT, MD; Phone Number: +334 90 14 81 81; Email: recherche.na@elsan.care
  • Besançon, France, 25000
    • Recruiting
    • Clinique St Vincent
    • Contact: Clément DARCQ, MD; Phone Number: +333 81 48 28 28; Email: recherche.na@elsan.care
  • Bordeaux, France, 33074
    • Recruiting
    • Clinique St Augustin
    • Contact: Jean-Luc HOEPFFNER, MD; Phone Number: +335 56 00 30 30; Email: recherche.na@elsan.care
  • Cabestany, France, 66330
    • Recruiting
    • Polyclinique Médipôle St-Roch
    • Contact: Nicolas LETANG, MD; Phone Number: +334 28 63 10 10; Email: recherche.na@elsan.care
  • Caen, France, 14000
    • Not yet recruiting
    • Polyclinique du Parc
    • Contact: Rayan ATME, MD; Phone Number: +332 31 82 82 82; Email: recherche.na@elsan.care
  • Le Mans, France, 72100
    • Recruiting
    • Pole Sante Sud-CMCM
    • Contact: Olivier BELAS, MD; Phone Number: +332 43 78 38 38; Email: recherche.na@elsan.care
  • Nancy, France, 54100
    • Not yet recruiting
    • Hôpital Privé Nancy Lorraine
    • Contact: Nicolas HUBERT, MD; Phone Number: +333 83 93 50 00; Email: recherche.na@elsan.care
  • Ollioules, France, 83190
    • Recruiting
    • Polyclinique Les Fleurs
    • Contact: Olivier ALENDA, MD; Phone Number: +334 83 08 62 57; Email: recherche.na@elsan.care
  • Saint-Herblain, France, 44800
    • Not yet recruiting
    • Polyclinique santé atlantique
    • Contact: Quentin Come LE CLERC, MD; Phone Number: +332 40 95 93 93; Email: recherche.na@elsan.care
  • Saint-Martin d'Hères, France, 38400
    • Recruiting
    • Clinique Belledonne
    • Contact: Jean-Alexandre LONG, MD; Phone Number: +334 38 38 02 02; Email: recherche.na@elsan.care
  • Soyaux, France, 16800
    • Not yet recruiting
    • Centre Clinical
    • Contact: Olivier LAPOUGE, MD; Phone Number: +335 45 97 88 00; Email: recherche.na@elsan.care
  • Vannes, France, 56000
    • Recruiting
    • Hôpital privé Océane
    • Contact: Hervé MONSAINT, MD; Phone Number: +332 97 62 57 30; Email: recherche.na@elsan.care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient procedure	Procedure: radical prostatectomy; Robot-assisted
Active Comparator: Inpatient procedure	Procedure: radical prostatectomy; Robot-assisted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early complication of robot-assisted prostatectomy	The occurrence (yes/no) of at least one early complication of robot-assisted prostatectomy. The early clinical complications expected are : Bleeding from trocar incision scars or surgical excision scars; Urinary leakage around the catheter; Retention due to bladder catheter clotting; Loss of bladder catheter; Signs of internal haemorrhage (within 24 hours); Signs of biological deglobulation; Intestinal obstruction syndrome; Signs of urinary fistula; Infectious signs : fever > 38°, chills; Thromboembolicaccidents; Nosocomial infections; Falls	From the day of surgery to 8 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)	Patients treated on an outpatient basis for whom full hospitalisation is indicated on the day of surgery, as decided by the medical team.	Day of surgery
Rate of cancellation of outpatient treatment by the patient or his private environment	Patients included in the study refusing outpatient care up to the day of surgery (before or after surgery) for whatever reason	From enrollment to the day of surgery
Rate of patients readmitted to hospital, either as emergencies or in the department	Patients readmitted to hospital (yes/no), emergency or inpatient department	From hospital discharge to 8 days post-operative.
Association of each early complication with treatment (outpatient or inpatient)	Early complication of robot-assisted prostatectomy	From hospitalisation discharge to 8 days post-operative
Rate of patients having had at least one complication secondary to surgery	Patients who had at least one complication secondary to surgery. The expected complications secondary to surgery are: Admission to emergency care; Re-hospitalization; Occlusions; Healing problems; Perineal hematoma; Urinary infections; Lymphoceles; Thromboembolic accidents; Nosocomial infections	From 8 days to 45 days post-operative
Rate of patients with at least one complication secondary to surgery	Patients who had at least one complication secondary to surgery.	From 45 days to 6 months post-operative
Patient's pre-operative stress/anxiety levels	The participant's stress/anxiety level is assessed at 3 days before surgery using the APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire validated in French (Moerman and al, 1996; Maurice-Szamburski and al, 2013), then with a Numerical Scale of stress/anxiety during preparation for the operating theatre in the care unit and at 2 days post-operative.	3 days before surgery, day of surgery and 2 days post-operative
Patient satisfaction level	Patient satisfaction is assessed using the overall satisfaction question in the e-SATIS questionnaire ("Overall, how would you rate the quality of your treatment/care in the department by the doctors/surgeons/nurses? Bad/Weak/Average/Good/Excellent) The patient's opinion (yes/no) is evaluated on whether, if the procedure were repeated, the patient would accept it (yes/no) and whether it reassured him/her to go home in the evening /stay in hospital at night after the procedure.	2 days and 45 days post-operative
Duration of surgery	Duration of surgery 'skin-to-skin' (incision until final stitch complete)	Day of surgery
Blood loss	The level of blood loss is assessed by the quantity of blood recovered in the aspiration jar and the quantity from the drains minus the quantity perfused intraoperatively in ml.	Day of surgery
Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery	Urinary continence is assessed by the response to question 5 of the EPIC-50 (Expanded Prostate Cancer Index Composite) when 0 to 1 pads are used during the day by the patient. Recovery of urinary function was assessed by the difference between the incontinence subscore of the EPIC-50 questionnaire at D45 and the value of the pre-operative score. The incontinence subscore include questions 1, 3, 4, 5 and 6a of the urinary function EPIC-50 questionnaire. The EPIC-50 is a validated questionnaire (Wei and al, 2000) and translated into French (Anota and al, 2016).	Baseline and 45 days post-operative
Evolution of urinary continence between 45 days and 6 months post-operatively and evolution of urinary function pre-operatively, at 45 days, at 6 months.	The evolution of continence and urinary function is established on the basis of the parameters defined previously (see Secondary Outcome Measure 12.)	Baseline and 45 days, 6 months after surgery
Recovery of erectile function	Erectile recovery is assessed using the IIEF-5 (International Index of Erectile Function) questionnaire (Rosen R and al, 1997; Dargis and al, 2013) ; erectile dysfunction is defined by an IIEF-5 score <10.	Baseline and 6 months post-operative
Oncological recurrence and retreatment	Recurrence is defined by a PSA (Prostate Specific Antigen) level >0.1ng/ml, the patient's re-treatment (yes/no), the type of re-treatment (hormone therapy / chemotherapy / radiotherapy).	From 45 days to 5 years after surgery
Economic and social cost of patient care	The cost-utility ratio calculated on the basis of : - The costs of the homogeneous group of patients (GHM) for hospitalisation and the costs of the national care reference system (ENCC) for post-operative management, based on the patient's diary completed up to 6 months after the operation. The following direct medical costs will be estimated from a societal perspective with a time horizon of 6 months: Medical transport, medical and non-medical consultations in town, complementary examinations and drugs: collected in the CRF of the study from the patient logbook and valued using current tariffs.; The QALY, a unit for measuring life expectancy weighted by health-related quality of life, calculated on the basis of the utility derived from the EQ-5D-5L quality of life questionnaire completed by the patient at D0, D45 and 6 months after surgery.	From hospital discharge to 6 months post-operative

Collaborators and Investigators

• Sponsor: Elsan

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PROSTAMBU; 2024-A01745-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No