New prostate surgery technique aims to save erections and bladder control
NCT ID NCT03317990
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This trial tests a new surgical method called NeuroSAFE, which uses real-time tissue analysis during robotic prostate removal to help surgeons avoid damaging nerves that control erections and bladder function. About 407 men with prostate cancer will be randomly assigned to receive either the standard surgery or the NeuroSAFE technique. The main goal is to see if the new approach leads to better erectile function one year after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NeuroSAFE procedure (a surgical technique involving real-time analysis of removed tissue to guide nerve-sparing decisions)
- What this could lead to
- If successful, this technique could help men undergoing prostate cancer surgery retain better erectile function and urinary control, improving their quality of life.
- What could go wrong
- This is a relatively early-stage trial (IDEAL stage 3) with 407 participants, so results may not apply to all men. The technique requires specialized training and may not be widely available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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407 people
The number who actually took part.
- Started
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Apr 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men opting to undergo RARP for organ confined prostate cancer. 2. Potent men (IIEF 22-25 not using PDE5i or other medications or vacuum pump) 3. Men who are continent of urine (no self-reported urinary incontinence) 4. Has given written informed consent 5. Ability to read English sufficiently to answer questionnaires and understand PIS Exclusion Criteria: 1. Unable to undergo robotic prostatectomy 2. Known urinary incontinence 3. Previous treatment for prostate cancer 4. Previous/current hormone treatment for prostate cancer 5. Nerve sparing deemed futile due to locally advanced disease by surgeon and radiologist
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
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North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
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Nottingham University Hospitals
Nottingham, United Kingdom
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Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
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University College London Hospital
London, NW1 2BU, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?