NCT03317990Active, not recruiting
Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.
A Single Blinded, IDEAL Stage 3, Multi-Centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) vs Standard Robotic Assisted Radical Prostatectomy (RARP) in Men With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
In summary this trial will test whether this new surgical technique can be used to make surgery safer and more effective whilst allowing improved quality of life for patients having surgery for prostate cancer. If the technique is proven effective the investigators will use the experience gained to promote its use throughout the NHS through training courses and publication and dissemination of the resultant data. Staff from centres participating in this trial will be fully trained in the NeuroSAFE technique. A patient and public involvement afternoon was held for participants of the NeuroSAFE PROOF feasibility study, family members, men with prostate cancer, and staff members at UCLH. The event was supported by the charity Orchid Cancer appeal. The high levels of attendance was demonstrative of the support within our patient group for the work of this trial. The trial team listened to the comments made by participants and members of the public and have made some changes to the design of our trial as a result of this feedback.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 407 (actual)
- First submitted
- 5 Oct 2017
- Start date
- 9 Apr 2018
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- University College, London
- Diseases
- Prostate cancer
- NCT number
- NCT03317990
What you commit to
- Study type: Interventional
- Participants enrolled: 407
- From 9 Apr 2018 to the primary completion date, 30 Apr 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for prostate cancer
- Previous/current hormone treatment for prostate cancer
Other illness
- Nerve sparing deemed futile due to locally advanced disease by surgeon and radiologist
Other
- Unable to undergo robotic prostatectomy
- Known urinary incontinence
Who the study is looking for
- Men opting to undergo RARP for organ confined prostate cancer.
- Potent men (IIEF 22-25 not using PDE5i or other medications or vacuum pump)
- Men who are continent of urine (no self-reported urinary incontinence)
- Has given written informed consent
- Ability to read English sufficiently to answer questionnaires and understand PIS
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Bristol NHS Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| NHS Greater Glasgow & Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Nottingham University Hospitals Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
Related publications
- Deep learning for fluorescence confocal microscopy image interpretation in radical prostatectomy.BJU Int · 2026 · PMID 42001901
- Intraoperative margin assessment using fluorescence confocal microscopy during robot-assisted radical prostatectomy: a first experience.BJU Int · 2026 · PMID 41877464
- Feasibility and workflow analysis of confocal microscopy in robot-assisted prostatectomy.BJU Int · 2026 · PMID 41655999
- The cost-effectiveness of intraoperative margin assessment strategies during radical prostatectomy.BJU Int · 2026 · PMID 41568609
This page is information, not medical advice. Discuss any trial with your doctor.