Prostate CancerROBOTCAPNCT02784314
Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy
A study testing Robotic-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy in people with Prostate Cancer, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Robotic-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFrance
- Study dates
- May 2010to Aug 2016
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Localized prostate cancer
- Gleason grade ≤ 3 + 4
- PSA < 15 ng / mL
- Stage ≤ T2b
- Eligible to receive laparoscopic radical prostatectomy
- Candidate bilateral or unilateral erectile preservation
Who cannot join
- Patient at high risk of postoperative progression (PSA> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
- Presenting erectile dysfunction (IIEF < 22)
- Past history of urinary incontinence (> grade 1 WHO)
- Body mass index > 30
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'Urologie - Clinique St Augustin
Bordeaux, 33074
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon
Lyon, 69437
Service d'Urologie - Institut Mutualiste Montsouris
Paris, 75014
About this study
Official title: Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).
- Conditions
- Prostate Cancer
- Being tested
- Robotic-Assisted Radical Prostatectomy, Laparoscopic Radical Prostatectomy
- Keywords
- Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Assisted Radical ProstatectomyProcedure or surgery
Laparoscopic Radical ProstatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Radical Prostatectomy | Experimental | Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System Receives: Procedure: Robotic-Assisted Radical Prostatectomy |
| Laparoscopic Radical Prostatectomy | Active comparator | Standard laparoscopic Radical Prostatectomy Receives: Procedure: Laparoscopic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function
Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.
Measured: 12 months after surgery
Secondary outcomes (6)
Surgical margins
Measured: During surgery
Prostate Specific Antigen (PSA)
Measured: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Continence
Continence is assessed by the International Prostate Symptom Score (IPSS)
Measured: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Tolerance
Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery
Measured: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
Quality of life
Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores
Measured: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
Incremental cost-effectiveness ratio
Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment
Measured: 60 months afet surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionAug 2016
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784314
- Sponsor's protocol ID
- 2009.587
- Acronym
- ROBOTCAP
- Status last verified
- Jun 2017
- First submitted
- 20 May 2016
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02784314
- Acronym / sponsor ID
- ROBOTCAP / 2009.587
- Conditions
- Prostate Cancer
- Keywords
- Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- 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.
In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Radical Prostatectomy | Experimental | Procedure: Robotic-Assisted Radical ProstatectomyRobotic-Assisted Radical Prostatectomy using da Vinci Surgical System |
| Laparoscopic Radical Prostatectomy | Active comparator | Procedure: Laparoscopic Radical ProstatectomyStandard laparoscopic Radical Prostatectomy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Localized prostate cancer
- Gleason grade ≤ 3 + 4
- PSA < 15 ng / mL
- Stage ≤ T2b
- Eligible to receive laparoscopic radical prostatectomy
Key exclusion criteria (4 listed)
- Patient at high risk of postoperative progression (PSA> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
- Presenting erectile dysfunction (IIEF < 22)
- Past history of urinary incontinence (> grade 1 WHO)
- Body mass index > 30
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 |
|---|---|---|
| Robotic-Assisted Radical Prostatectomy | Procedure or surgery | Robotic-Assisted Radical Prostatectomy |
| Laparoscopic Radical Prostatectomy | Procedure or surgery | Laparoscopic Radical Prostatectomy |
Primary outcome
Erectile function
Time frame: 12 months after surgery
Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.
6 secondary outcomes
Surgical margins
Time frame: During surgery
Prostate Specific Antigen (PSA)
Time frame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Continence
Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Tolerance
Time frame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
Quality of life
Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
Incremental cost-effectiveness ratio
Time frame: 60 months afet surgery
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 Jun 2017.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy in people with Prostate Cancer, run by Hospices Civils de Lyon at 3 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 6 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: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Erectile function (time frame: 12 months after 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 5 Jun 2017.