Prostate CancerPROSTA-RAACNCT05172986
Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
A study testing Follow-up patient program in people with Prostate Cancer and Quality of Life, run by Elsan at 1 site in France.
Trial summary
There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3). Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Quality of Life, Recovery Programm
- What is being tested?
- Follow-up patient program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male over 40 and under 75
- Patient scheduled for a robot assisted radical prostatectomy within the center
- Affiliation to a social security scheme or beneficiary of such a scheme
- Patient having signed the free and informed consent
Who cannot join
- Minor, age ≤ 40 years or ≥ 75 years
- ASA 4 or more
- Severe or poorly balanced associated conditions
- Covid + declared in the previous 3 months
- Refusal to participate in the study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).
This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.
Read the detailed description
The implementation of RAAC programs in healthcare establishments would improve the quality and safety of patient care (functional development and rapid convalescence of patients and reduction in postoperative morbidity through active prevention of perioperative complications) and optimization of care costs for health establishments and for health insurance (reduction in length of stay and convalescence, reduction in postoperative complications). Its implementation requires a strong involvement of all the teams and a transversal and multidisciplinary coordination, specifically dedicated to one type of intervention. This approach must therefore show its effectiveness by specialty and then by pathology within the same specialty.
There are few published data on the benefit of RAAC in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).
This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.
- Conditions
- Prostate Cancer, Quality of Life, Recovery Programm
- Being tested
- Follow-up patient program
- Keywords
- Robotic assisted
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up patient programBehavioural
An additional paramedical visit will be carried out before the surgery. The interview is carried out by the healthcare team. An organization within the service has been set up so that a nurse can be totally seconded for the RAAC mission. The consultation lasts 30 to 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| RAAC (Program Arm) | Experimental | Patient under RAAC Program Receives: Behavioral: Follow-up patient program |
| Standard Arm | No intervention | Standard patient procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative stay of RAAC-type treatment
To assess the length of postoperative stay of RAAC-type treatment compared to standard treatment, during a robotic-assisted radical prostatectomy.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start27 Oct 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172986
- Sponsor's protocol ID
- 2020-A03292-37
- Acronym
- PROSTA-RAAC
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pierquet G, Prevost E, Lopez L, Gaston R, Rouffilange J, Riviere J, Roche JB, Vuong N, Genty A, Hoepffner JL, Asimakopoulos AD, Piechaud PT. Enhanced recovery after surgery protocol does not reduce the length of postoperative hospitalization after robot-assisted radical prostatectomy. Outcomes from the first randomized controlled trial: the (PROSTA-RAAC) study. World J Urol. 2025 Nov 15;43(1):699. doi: 10.1007/s00345-025-06078-2.
PubMed 41240114
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
- ClinicalTrials.gov ID
- NCT05172986
- Acronym / sponsor ID
- PROSTA-RAAC / 2020-A03292-37
- Conditions
- Prostate Cancer, Quality of Life, Recovery Programm
- Keywords
- Robotic assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Dec 2021 (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.
There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).
This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.
Detailed description
The implementation of RAAC programs in healthcare establishments would improve the quality and safety of patient care (functional development and rapid convalescence of patients and reduction in postoperative morbidity through active prevention of perioperative complications) and optimization of care costs for health establishments and for health insurance (reduction in length of stay and convalescence, reduction in postoperative complications). Its implementation requires a strong involvement of all the teams and a transversal and multidisciplinary coordination, specifically dedicated to one type of intervention. This approach must therefore show its effectiveness by specialty and then by pathology within the same specialty.
There are few published data on the benefit of RAAC in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).
This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAAC (Program Arm) | Experimental | Behavioral: Follow-up patient programPatient under RAAC Program |
| Standard Arm | No intervention | –Standard patient procedure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male over 40 and under 75
- Patient scheduled for a robot assisted radical prostatectomy within the center
- Affiliation to a social security scheme or beneficiary of such a scheme
- Patient having signed the free and informed consent
Key exclusion criteria (6 listed)
- Minor, age ≤ 40 years or ≥ 75 years
- ASA 4 or more
- Severe or poorly balanced associated conditions
- Covid + declared in the previous 3 months
- Refusal to participate in the study
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 |
|---|---|---|
| Follow-up patient programAn additional paramedical visit will be carried out before the surgery. The interview is carried out by the healthcare team. An organization within the service has been set up so that a nurse can be totally seconded for the RAAC mission. The consultation lasts 30 to 45 minutes. | Behavioural | RAAC (Program Arm) |
Primary outcome
postoperative stay of RAAC-type treatment
Time frame: 5 days
To assess the length of postoperative stay of RAAC-type treatment compared to standard treatment, during a robotic-assisted radical prostatectomy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 41240114Pierquet G, Prevost E, Lopez L, Gaston R, Rouffilange J, Riviere J, Roche JB, Vuong N, Genty A, Hoepffner JL, Asimakopoulos AD, Piechaud PT. Enhanced recovery after surgery protocol does not reduce the length of postoperative hospitalization after robot-assisted radical prostatectomy. Outcomes from the first randomized controlled trial: the (PROSTA-RAAC) study. World J Urol. 2025 Nov 15;43(1):699. doi: 10.1007/s00345-025-06078-2.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up patient program in people with Prostate Cancer and Quality of Life, run by Elsan at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative stay of RAAC-type treatment (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172986, which also lists 1 linked publication.
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 5 Jan 2024.