Prostate CancerEMUPRONCT04638088
Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy
An observational study of Prostate Cancer, run by Elsan at 30 sites in France.
Trial summary
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- assessment of urinary function and erectil function before and after prostatectomy
- How many people
- 2,000 participants
- Where
- 30 sitesFrance
- Study dates
- 8 Mar 2021to 30 Apr 2030
- Phase
- Observational
- 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
Study population: patient hospitalized for a planned radical prostactectomy .
Who may be able to join
- patient hospitalized for a planned radical prostatectomy
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
France30 sites, 9 recruiting
- Recruiting
Clinique Esquirol Saint Hilaire
Agen, 47000
Xavier CUVILLIER, MD, 00335 53 69 27 15, xcuvillier@yahoo.fr
Xavier CUVILLIER, MD
- Completed
Clinique Rhône Durance
Avignon, 84000
- Completed
Hôpital Privé La Châtaigneraie
Beaumont, 63110
- Completed
Clinique St Vincent
Besançon, 25000
- Completed
Polyclinique de Franche Comté
Besançon, 25000
- Completed
Clinique de Saint Augustin
Bordeaux, 33074
- Recruiting
Clinique Keraudren - CHPB
Brest, 29200
Maxime THOULOUZAN, MD, 00332 98 34 29 42, maxime.thoulouzan@keraudren-grandlarge.fr
Maxime THOULOUZAN, MD
- Recruiting
Centre Médico-Chirurgical Les Cèdres
Brive-la-Gaillarde, 19100
Pascal BOURNEL, MD, pascal.bournel@sfr.fr
Pascal BOURNEL, MD
- Completed
Polyclinique Médipôle Saint-Roch
Cabestany, 6633
- Completed
Polyclinique du Parc
Caen, 14000
- Recruiting
Polyclinique Montréal
Carcassonne, 11000
Frédéric VAVDIN, MD, urovavdin@gmail.com
Frédéric VAVDIN, MD
- Recruiting
Pôle Santé République
Clermont-Ferrand, 63100
Arnaud SCHOENIG, MD, 00334 73 99 49 49, arnaud.schoenig@gmail.com
Arnaud SCHOENIG, MD
- Withdrawn
Hôpital Privé Saint-François
Désertines, 03630
- Completed
Clinique Cap-d'Or
La Seyne-sur-Mer, 83500
- Completed
Pôle Santé Sud
Le Mans, 72000
- Recruiting
Clinique Emailleurs-Colombier
Limoges, 87000
Nicolas LESAUX, MD, nicolas.lesaux@orange.fr
Nicolas LESAUX, MD
- Completed
Polyclinique de Limoges
Limoges, 87000
- Withdrawn
Clinique Claude Bernard
Metz, 57070
- Completed
Polyclinique de Gentilly
Nancy, 54100
- Completed
Clinique Saint-Augustin
Nantes, 44000
- Completed
Polyclinique Grand Sud
Nîmes, 30900
- Completed
Polyclinique Les Fleurs
Ollioules, 83190
- Recruiting
Polyclinique de Poitiers
Poitiers, 86000
Christian PEYRET, MD, christian.peyret@orange.fr
Christian PEYRET, MD
- Recruiting
Clinique du Renaison
Roanne, 42300
Thierry BETHMONT, MD, thierrybethmont@wanadoo.fr
Thierry BETHMONT, MD
- Completed
Clinique Guillaume De Varye
Saint-Doulchard, 18230
- Completed
Centre clinical
Soyaux, 16800
- Completed
Clinique de l'Estrée
Stains, 93240
- Recruiting
Clinique Ambroise Paré
Toulouse, 31082
Frédéric JONCA, MD, frederic.jonca@numericable.fr
Frédéric JONCA, MD
- Completed
Polyclinique Vauban
Valenciennes, 59300
- Completed
Hôpital privé Océane
Vannes, 56000
About this study
Official title: Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
Read the detailed description
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
- Conditions
- Prostate Cancer
- Being tested
- assessment of urinary function and erectil function before and after prostatectomy
- Keywords
- robot-assisted laparoscopy, laparotomy, conventional laparoscopy, prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of urinary function and erectil function before and after prostatectomyOther
assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted laparoscopy | radical prostatectomy performed by robot-assisted laparoscopy Receives: Other: assessment of urinary function and erectil function before and after prostatectomy | |
| conventional laparoscopy | radical prostatectomy performed by conventional laparoscopy Receives: Other: assessment of urinary function and erectil function before and after prostatectomy | |
| laparotomy | radical prostatectomy performed by laparotomy Receives: Other: assessment of urinary function and erectil function before and after prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite)
Measured: 45 Days after the surgery
Secondary outcomes (7)
impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score
impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy on the erectile function assessed by he EPIC 50 score (Expanded Prostate Cancer Index Composite)
Measured: 45 Days after the surgery
impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
Measured: up to 5 years after surgery
impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score
Measured: upt to 5 years after the surgery
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Measured: 12 months
Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )
Measured: 3 years
Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )
Measured: 5 years
Prostate Specific Antigen (PSA) level
measures of the level of PSA in a man's blood
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Mar 2021
- Primary completion21 Jul 2025
- 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 CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahnaz KLOUCHE, MD, Study director, ElsanPierre-Thierry PIECHAUD, MD, Principal investigator, Elsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638088
- Sponsor's protocol ID
- GCS-ELSAN-0620
- Acronym
- EMUPRO
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.
- ClinicalTrials.gov ID
- NCT04638088
- Acronym / sponsor ID
- EMUPRO / GCS-ELSAN-0620
- Conditions
- Prostate Cancer
- Keywords
- robot-assisted laparoscopy, laparotomy, conventional laparoscopy, prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 20 Nov 2020 (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.
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
Detailed description
Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| robot-assisted laparoscopy | – | Other: assessment of urinary function and erectil function before and after prostatectomyradical prostatectomy performed by robot-assisted laparoscopy |
| conventional laparoscopy | – | Other: assessment of urinary function and erectil function before and after prostatectomyradical prostatectomy performed by conventional laparoscopy |
| laparotomy | – | Other: assessment of urinary function and erectil function before and after prostatectomyradical prostatectomy performed by laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient hospitalized for a planned radical prostactectomy .
Key inclusion criteria (1 listed)
- patient hospitalized for a planned radical prostatectomy
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| assessment of urinary function and erectil function before and after prostatectomyassessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete | Other | conventional laparoscopy, laparotomy, robot-assisted laparoscopy |
Primary outcome
Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score
Time frame: 45 Days after the surgery
Comparison of the prostatectomy performed by robot assisted laparoscopy or conventional laparoscopy and by surgical laparotomy on the urinary function assessed by the EPIC 50 score (Expanded Prostate Cancer Index Composite)
7 secondary outcomes
impact of the robot assisted laparoscopy compared to conventional laparoscopy and by surgical laparotomy in radical prostatectomy on the erectile function assessed by the EPIC 50 score
Time frame: 45 Days after the surgery
impact of the robot assisted laparoscopy in prostatectomy on the urinary function assessed by EPIC 50 SCORE
Time frame: up to 5 years after surgery
impact of the robot assisted laparoscopy in prostatectomy on the erectile function assessed by the International Index of Erectile Function (IIEF-5) score
Time frame: upt to 5 years after the surgery
Assessment of the cost effectiveness of the robot assisted procedure in prostatectomy assessed by EQ5d-5L score
Time frame: 12 months
Occurence of prostatectomy sequelae (urinary incontinence or erectile dysfunction )
Time frame: 3 years
Occurence of prostatectomy sequelae (urinary incontinence or erectil dysfunction )
Time frame: 5 years
Prostate Specific Antigen (PSA) level
Time frame: up to 5 years
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 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shahnaz KLOUCHE, MD study director
Elsan
Pierre-Thierry PIECHAUD, MD principal investigator
Elsan
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Elsan at 30 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 1 inclusion and 3 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 Shahnaz KLOUCHE, MD (00331 58 56 41 71, klouche@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the prostatectomy procedure (robot assisted laparoscopy, conventional laparoscopy and surgical laparotomy) on the urinary function assessed by the EPIC 50 score (time frame: 45 Days after the surgery). 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 21 Apr 2026.