Prostate Cancer SurgeryPROSTAMBUNCT06822452
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
A study testing radical prostatectomy in people with Prostate Cancer Surgery and Ambulatory Care, run by Elsan at 12 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Surgery, Ambulatory Care, Outpatient Surgery
- What is being tested?
- radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 12 sitesFrance
- Study dates
- 30 Dec 2024to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
- The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
- 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)
- The patient has access to telephone communication facilities.
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- 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.
- 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).
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Not yet recruiting
Clinique Rhône Durance
Avignon, 84000
Christophe CLEMENT, MD, +334 90 14 81 81, recherche.na@elsan.care
- Recruiting
Clinique St Vincent
Besançon, 25000
Clément DARCQ, MD, +333 81 48 28 28, recherche.na@elsan.care
- Recruiting
Clinique St Augustin
Bordeaux, 33074
Jean-Luc HOEPFFNER, MD, +335 56 00 30 30, recherche.na@elsan.care
- Recruiting
Polyclinique Médipôle St-Roch
Cabestany, 66330
Nicolas LETANG, MD, +334 28 63 10 10, recherche.na@elsan.care
- Not yet recruiting
Polyclinique du Parc
Caen, 14000
Rayan ATME, MD, +332 31 82 82 82, recherche.na@elsan.care
- Recruiting
Pole Sante Sud-CMCM
Le Mans, 72100
Olivier BELAS, MD, +332 43 78 38 38, recherche.na@elsan.care
- Not yet recruiting
Hôpital Privé Nancy Lorraine
Nancy, 54100
Nicolas HUBERT, MD, +333 83 93 50 00, recherche.na@elsan.care
- Recruiting
Polyclinique Les Fleurs
Ollioules, 83190
Olivier ALENDA, MD, +334 83 08 62 57, recherche.na@elsan.care
- Not yet recruiting
Polyclinique Santé Atlantique
Saint-Herblain, 44800
Quentin Come LE CLERC, MD, +332 40 95 93 93, recherche.na@elsan.care
- Recruiting
Clinique Belledonne
Saint-Martin-d'Hères, 38400
Jean-Alexandre LONG, MD, +334 38 38 02 02, recherche.na@elsan.care
- Not yet recruiting
Centre clinical
Soyaux, 16800
Olivier LAPOUGE, MD, +335 45 97 88 00, recherche.na@elsan.care
- Recruiting
Hôpital Privé Océane
Vannes, 56000
Hervé MONSAINT, MD, +332 97 62 57 30, recherche.na@elsan.care
About this study
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
- Conditions
- Prostate Cancer Surgery, Ambulatory Care, Outpatient Surgery
- Being tested
- radical prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical prostatectomyProcedure or surgery
Robot-assisted
| Study group | Role | What they receive |
|---|---|---|
| Outpatient procedure | Experimental | Not described Receives: Procedure: radical prostatectomy |
| Inpatient procedure | Active comparator | Not described Receives: Procedure: radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the day of surgery to 8 days post-operative
Secondary outcomes (15)
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.
Measured: 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
Measured: 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
Measured: From hospital discharge to 8 days post-operative.
Association of each early complication with treatment (outpatient or inpatient)
Early complication of robot-assisted prostatectomy
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 days and 45 days post-operative
Duration of surgery
Duration of surgery 'skin-to-skin' (incision until final stitch complete)
Measured: 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.
Measured: 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).
Measured: 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.)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From hospital discharge to 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start30 Dec 2024
- Primary completion7 Jan 2027 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822452
- Sponsor's protocol ID
- PROSTAMBU
- Other IDs
- 2024-A01745-42
- Acronym
- PROSTAMBU
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.
- ClinicalTrials.gov ID
- NCT06822452
- Acronym / sponsor ID
- PROSTAMBU / PROSTAMBU
- Conditions
- Prostate Cancer Surgery, Ambulatory Care, Outpatient Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient procedure | Experimental | Procedure: radical prostatectomy |
| Inpatient procedure | Active comparator | Procedure: radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 :
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radical prostatectomyRobot-assisted | Procedure or surgery | Inpatient procedure, Outpatient procedure |
Primary outcome
Early complication of robot-assisted prostatectomy
Time frame: From the day of surgery to 8 days post-operative
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
15 secondary outcomes
Conversion rate from outpatient to full hospitalisation (Outpatient failure rate)
Time frame: Day of surgery
Rate of cancellation of outpatient treatment by the patient or his private environment
Time frame: From enrollment to the day of surgery
Rate of patients readmitted to hospital, either as emergencies or in the department
Time frame: From hospital discharge to 8 days post-operative.
Association of each early complication with treatment (outpatient or inpatient)
Time frame: From hospitalisation discharge to 8 days post-operative
Rate of patients having had at least one complication secondary to surgery
Time frame: From 8 days to 45 days post-operative
Rate of patients with at least one complication secondary to surgery
Time frame: From 45 days to 6 months post-operative
Patient's pre-operative stress/anxiety levels
Time frame: 3 days before surgery, day of surgery and 2 days post-operative
Patient satisfaction level
Time frame: 2 days and 45 days post-operative
Duration of surgery
Time frame: Day of surgery
Blood loss
Time frame: Day of surgery
Rate of patients who recovered continence and rate of patients who recovered urinary function after surgery
Time frame: 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.
Time frame: Baseline and 45 days, 6 months after surgery
Recovery of erectile function
Time frame: Baseline and 6 months post-operative
Oncological recurrence and retreatment
Time frame: From 45 days to 5 years after surgery
Economic and social cost of patient care
Time frame: From hospital discharge to 6 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radical prostatectomy in people with Prostate Cancer Surgery and Ambulatory Care, run by Elsan at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlène PY, Eng (+33556003048, charlene.py@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complication of robot-assisted prostatectomy (time frame: From the day of surgery to 8 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.