Prostate CancerNCT03787823
RCT-evaluation of Retzius-sparing Robotic Prostatectomy
A study testing robotic Prostatectomy (RARP) in people with Prostate Cancer and Urinary Incontinence, run by Heidelberg University at 1 site in Germany.
Trial summary
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence
- What is being tested?
- robotic Prostatectomy (RARP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- 27 Aug 2018to 30 Nov 2020
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for radical prostatectomy
- >18 years old
- Literate
- Preoperatively continent
- informed signed consent for study
Who cannot join
- cT4-Cancer
- Withdrawl of consent to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy
Read the detailed description
We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months
- Conditions
- Prostate Cancer, Urinary Incontinence
- Being tested
- robotic Prostatectomy (RARP)
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic Prostatectomy (RARP)Procedure or surgery
Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP
| Study group | Role | What they receive |
|---|---|---|
| Retzius-sparing RARP | Other | Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP Receives: Procedure: robotic Prostatectomy (RARP) |
| anterior transperitoneal RARP | Other | Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP Receives: Procedure: robotic Prostatectomy (RARP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary continence
Pad use
Measured: 1 Week after Prostatectomy
Secondary outcomes (4)
Resection margine
Measured: pathology report, approximately 1 week postoperatively
Urinary continence
Pad use
Measured: 3, 6 and 12 months after Prostatectomy
Postoperative complications
Measured: First 12 months after Prostatectomy
postoperative PSA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start27 Aug 2018
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Nov 2020 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne N. Nyarangi-Dix, M.D., Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787823
- Sponsor's protocol ID
- Transdouglas RCT-Study
- Status last verified
- Mar 2020
- First submitted
- 4 Sep 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: So far, no sharing planed
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
- ClinicalTrials.gov ID
- NCT03787823
- Acronym / sponsor ID
- Transdouglas RCT-Study
- Conditions
- Prostate Cancer, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 26 Dec 2018 (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.
Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy
Detailed description
We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retzius-sparing RARP | Other | Procedure: robotic Prostatectomy (RARP)Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP |
| anterior transperitoneal RARP | Other | Procedure: robotic Prostatectomy (RARP)Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indication for radical prostatectomy
- >18 years old
- Literate
- Preoperatively continent
- informed signed consent for study
Key exclusion criteria (2 listed)
- cT4-Cancer
- Withdrawl of consent to 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 |
|---|---|---|
| robotic Prostatectomy (RARP)Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP | Procedure or surgery | Retzius-sparing RARP, anterior transperitoneal RARP |
Primary outcome
Urinary continence
Time frame: 1 Week after Prostatectomy
Pad use
4 secondary outcomes
Resection margine
Time frame: pathology report, approximately 1 week postoperatively
Urinary continence
Time frame: 3, 6 and 12 months after Prostatectomy
Postoperative complications
Time frame: First 12 months after Prostatectomy
postoperative PSA
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: Undecided. So far, no sharing planed
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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 robotic Prostatectomy (RARP) in people with Prostate Cancer and Urinary Incontinence, run by Heidelberg University at 1 site in Germany.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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 Germany. 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?
Results are not available in the source record.
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?
Urinary continence (time frame: 1 Week after Prostatectomy). 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 24 Mar 2020.