Prostate Cancer (Localized), Urinary Incontinence (C61)ToP-RAPNCT07678489
Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy IDEAL Stage 2a
A study testing ToP-RAP in people with Prostate Cancer (Localized), Urinary Incontinence (C61), run by Sami-Ramzi Leyh-Bannurah at 2 sites in Germany.
Trial summary
Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Localized), Urinary Incontinence (C61)
- What is being tested?
- ToP-RAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Jan 2024to 31 Dec 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
- Life expectancy >=10 years (biological age)
- No prior prostate therapy (laser enucleation, TURP, focal therapy)
- No pelvic/prostate radiotherapy;
- No prior abdominal/rectal surgery;
- No prior (neoadjuvant) androgen-deprivation therapy
- No prior stroke/cerebral ischemia with neurological sequelae;
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- No neurological disease (e.g., Parkinson's)
- Transrectal or transperineal bilateral biopsy >=12 cores (MRI-ultrasound fusion, targeted + systematic)
- PSA <=15 ng/mL; prostate volume <=80 mL
- Biopsy ISUP grade 1-3 (= Gleason 3+3 / 3+4 / 4+3)
- No Gleason pattern 5; no intraductal, cribriform or neuroendocrine carcinoma
- mp/bpMRI (mandatory if biopsy Gleason >=3+4)
- No suspected metastases at staging
Who cannot join
- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Clinic Bel Etage
Düsseldorf, 40217
Jörn H Witt, Associate Professor, +492115426650, info@urokompetenz.de
- Recruiting
Diakonie Klinikum Jung-Stilling
Siegen, 57074
Mahmoud Farzat, MD, +492713334525, Mahmoud.Farzat@diakonie-sw.de
About this study
Official title: Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study
Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.
Read the detailed description
Our study introduces a urethra-preserving prostatectomy concept that maintains the entire intraprostatic urethra, thereby avoiding both urethral transection and vesicourethral anastomosis. We embed the technique in a transparent IDEAL-based framework with predefined intra-operative decision rules, including prespecified conversion to standard robot-assisted radical prostatectomy. This positions the technique as a distinct step beyond existing bladder neck- or urethra-sparing modifications, and provides the first prospective multicentre data supporting its feasibility in selected patients.
- Being tested
- ToP-RAP
- Keywords
- Prostatectomy, Urethral sparing, Urethra-preserving, NeuroSAFE, nerve-sparing, Focal therapy, IRE, HIFU, Urinary continence, Bladder-neck preservation, Hood technique, Sleeve technique, IDEAL framework, Retzius sparing, DaVinci, multiport, single port, HUGO RAS, Feasibility study, Prostatic neoplasms
- 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.
ToP-RAPProcedure or surgery
Also called * Total en bloc Urethra Preservation at Robot-assisted Prostatectomy, Total Urethral Length Preservation, TULP, TUP-RAP
ToP-RAP is a urethra-preserving modification of robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Its distinguishing feature is preservation of the entire intraprostatic urethra with complete omission of urethral transection and the vesicourethral anastomosis. This separates it mechanistically from standard RARP, Retzius-sparing RARP, and the hood and sleeve techniques - all of which transect the urethra and reconstruct a vesicourethral anastomosis - and from urethra-sparing *simple* prostatectomy, which is a benign (BPH) enucleation rather than whole-gland cancer surgery. The whole prostatic gland is removed while only the intraprostatic urethra is retained, with anterolateral neurovascular-bundle preservation.
| Study group | Role | What they receive |
|---|---|---|
| ToP-RAP | Experimental | Not described Receives: Procedure: ToP-RAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of ToP-RAP
Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.
Measured: Intraoperative (day of surgery)
Perioperative safety (Clavien-Dindo)
Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.
Measured: Up to 90 days after surgery
Time to urinary continence recovery
Days from surgery to urinary continence recovery defined as use of 0 or 1 safety pad per day. Inpatient continence is defined by Stamey criteria (medical expert assessment).
Measured: Up to 12 months after surgery
Secondary outcomes (2)
PSA persistence and biochemical recurrence
PSA persistence (failure to reach <0.1 ng/mL within 12 weeks) and biochemical recurrence (PSA >=0.2 ng/mL) assessed on serial PSA measurements.
Measured: 3, 6, 9, 12 and 24 months after surgery
Erectile function recovery
Post-ToP-RAP Erectile function recovery, measured via IIEF-5
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Jan 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Cancer (Localized), Urinary Incontinence (C61)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sami-Ramzi Leyh-Bannurah
- Sponsor type
- University, hospital or other
- Collaborators
- Clinic Bel Etage Dusseldorf, NRW, Germany
- Responsible party
- Sponsor-investigator, Sami-Ramzi Leyh-Bannurah, Jung Stilling Hospital
- Investigators
- Sami-Ramzi Leyh-Bannurah, Associate Professor, Study director, Martini Klinik am UKE GmbH, Hamburg-Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678489
- Sponsor's protocol ID
- 2025086
- Acronym
- ToP-RAP
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified patient-level data may be made available from the corresponding author upon reasonable request, subject to institutional approval and privacy/ethical restrictions.
Publications
Farzat M, Kachanov M, Vetterlein MW, Salomon G, Al Taie I, Oh-Hohenhorst SJ, Wagenlehner FM, John H, Witt JH, Leyh-Bannurah SR. Total en Bloc Urethra Preservation at Robot-Assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 1-2a Study. Cancers (Basel). 2026 Sep 28;18(19):3134. doi: 10.3390/cancers18193134.
PubMed 42882829
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study
- ClinicalTrials.gov ID
- NCT07678489
- Acronym / sponsor ID
- ToP-RAP / 2025086
- Keywords
- Prostatectomy, Urethral sparing, Urethra-preserving, NeuroSAFE, nerve-sparing, Focal therapy, IRE, HIFU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sami-Ramzi Leyh-BannurahUniversity, hospital or other
- Collaborators
- Clinic Bel Etage Dusseldorf, NRW, Germany
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Jul 2026 (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 single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.
Detailed description
Our study introduces a urethra-preserving prostatectomy concept that maintains the entire intraprostatic urethra, thereby avoiding both urethral transection and vesicourethral anastomosis. We embed the technique in a transparent IDEAL-based framework with predefined intra-operative decision rules, including prespecified conversion to standard robot-assisted radical prostatectomy. This positions the technique as a distinct step beyond existing bladder neck- or urethra-sparing modifications, and provides the first prospective multicentre data supporting its feasibility in selected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ToP-RAP | Experimental | Procedure: ToP-RAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Life expectancy >=10 years (biological age)
- No prior prostate therapy (laser enucleation, TURP, focal therapy)
- No pelvic/prostate radiotherapy;
- No prior abdominal/rectal surgery;
- No prior (neoadjuvant) androgen-deprivation therapy
Key exclusion criteria (1 listed)
- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)
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 |
|---|---|---|
| ToP-RAPAlso: * Total en bloc Urethra Preservation at Robot-assisted Prostatectomy, Total Urethral Length Preservation, TULP, TUP-RAPToP-RAP is a urethra-preserving modification of robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Its distinguishing feature is preservation of the entire intraprostatic urethra with complete omission of urethral transection and the vesicourethral anastomosis. This separates it mechanistically from standard RARP, Retzius-sparing RARP, and the hood and sleeve techniques - all of which transect the urethra and reconstruct a vesicourethral anastomosis - and from urethra-sparing *simple* prostatectomy, which is a benign (BPH) enucleation rather than whole-gland cancer surgery. The whole prostatic gland is removed while only the intraprostatic urethra is retained, with anterolateral neurovascular-bundle preservation. | Procedure or surgery | ToP-RAP |
Primary outcome
Technical feasibility of ToP-RAP
Time frame: Intraoperative (day of surgery)
Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.
Perioperative safety (Clavien-Dindo)
Time frame: Up to 90 days after surgery
Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.
Time to urinary continence recovery
Time frame: Up to 12 months after surgery
Days from surgery to urinary continence recovery defined as use of 0 or 1 safety pad per day. Inpatient continence is defined by Stamey criteria (medical expert assessment).
2 secondary outcomes
PSA persistence and biochemical recurrence
Time frame: 3, 6, 9, 12 and 24 months after surgery
Erectile function recovery
Time frame: Up to 24 months after surgery
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 1 Jul 2026.
- Derived from this study: PubMed 42882829Farzat M, Kachanov M, Vetterlein MW, Salomon G, Al Taie I, Oh-Hohenhorst SJ, Wagenlehner FM, John H, Witt JH, Leyh-Bannurah SR. Total en Bloc Urethra Preservation at Robot-Assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 1-2a Study. Cancers (Basel). 2026 Sep 28;18(19):3134. doi: 10.3390/cancers18193134.
- Individual participant dataSharing planned: No. De-identified patient-level data may be made available from the corresponding author upon reasonable request, subject to institutional approval and privacy/ethical restrictions.
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.
Sami-Ramzi Leyh-Bannurah, Associate Professor study director
Martini Klinik am UKE GmbH, Hamburg-Eppendorf, Hamburg, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ToP-RAP in people with Prostate Cancer (Localized), Urinary Incontinence (C61), run by Sami-Ramzi Leyh-Bannurah at 2 sites 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 13 inclusion and 1 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of ToP-RAP (time frame: Intraoperative (day of surgery)). The study lists 3 primary outcomes in all. 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 NCT07678489, 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 1 Jul 2026.