All studies
Active not recruitingNAINTERVENTIONAL

Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.

This study is investigating a new surgical technique called NeuroSAFE for men undergoing prostate removal due to prostate cancer. The main goal is to find out if this new approach can lead to better outcomes for patients, making surgery safer and more effective. It also aims to improve a man's quality of life after surgery, particularly regarding maintaining bladder control and sexual function. Currently, standard surgery might sometimes risk leaving cancer behind if surgeons try to protect important nerves, or it might damage these nerves leading to side effects. This trial hopes to reduce these trade-offs. The long-term aim is to share successful evidence of this new technique widely across the NHS.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University College, London
Enrolment target
407
Start
09 Apr 2018
Estimated completion
01 Dec 2027

Results

Results from this study

Posted September 2025

Results have been published for this study.

Primary outcome
Erectile Function
Comparison of the erectile function at 12-months according to allocated treatment arm (i.e. NeuroSAFE RARP \[intervention\] vs. standard RARP \[control\]). Erectile function is measured using the IIEF-5 questionnaire Measure Description: The International Index of Erectile Function-5 (IIEF-5) measures erectile dysfunction severity. Total scores range from 5 to 25, calculated by summing 5 items. Higher scores indicate better erectile function. Severity categories: 22-25 = no erectile disfunction, 17-21 = mild, 12-16 = mild to moderate, 8-11 = moderate, 5-7 = severe. No subscales are used; the total score is the sum of all items.
Full results on the registry

What is this study about?

Prostate cancer is a common illness that affects many men in the UK. If the cancer is still contained within the prostate gland and hasn't spread, surgery to remove the prostate (called a radical prostatectomy) is often a way to cure it.

However, this surgery can sometimes lead to side effects. For example, some men may have difficulty controlling their urine, and others might experience problems with erections. These issues can happen because the nerves that help with erections and bladder control are very close to the prostate and can sometimes be damaged during surgery. Surgeons try to protect these nerves to help men keep their quality of life, but there's a delicate balance: trying too hard to save nerves might, in some cases, risk leaving tiny cancer cells behind, which could mean needing more treatment like radiotherapy later on.

This study is testing a new surgical method called NeuroSAFE. The aim of NeuroSAFE is to help surgeons be more confident during the operation that they are removing all the cancer while also protecting the important nerves that affect bladder control and erections. By doing this, the researchers hope to reduce the need for further treatments like radiotherapy after surgery and improve men's quality of life. This research is especially important now because the types of prostate cancers being treated surgically are changing, and techniques used in the past for less aggressive cancers might not be as safe for the more aggressive cancers seen today. This study aims to ensure new techniques are thoroughly tested before they become widely used.

Key takeaways

  • This study evaluates a new surgical technique called NeuroSAFE for prostate cancer.
  • It aims to improve surgical safety, effectiveness, and patient quality of life.
  • The focus is on maintaining bladder control and sexual function after surgery.
  • It compares NeuroSAFE to standard robotic prostate removal.
  • The research seeks to reduce the need for further treatments like radiotherapy.
  • Patient feedback has already helped shape the study design.

Who may be eligible?

This study is for men aged 18 to 75 who are planning to have their prostate removed due to prostate cancer that hasn't spread beyond the prostate gland. To be considered, you should be able to have erections without using medication or pumps, and you shouldn't have any issues with controlling your urine before the surgery.

You would not be able to join the study if you can't have robotic surgery, already have problems with urine leakage, or have had any previous treatment for prostate cancer, including hormone therapy. Also, if your doctors believe that preserving the nerves around your prostate during surgery would be too risky because of how advanced your cancer is, then this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a man between 18 and 75 years old?
  2. Are you having surgery to remove your prostate for cancer that hasn't spread?
  3. Can you currently get erections without medication or pumps?
  4. Do you currently have good control over your bladder (no urine leakage)?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully described in this summary. However, generally, if you participate in a study like this, you would undergo the planned prostate removal surgery using either the new NeuroSAFE technique or the standard robotic surgery method. You would likely have regular follow-up appointments with your medical team over some time, which could include examinations, blood tests, and filling out questionnaires. These questionnaires would help the researchers understand how the surgery has affected your quality of life, including your bladder control and sexual function. The total duration of your participation, including follow-up, would be determined by the study design.

Potential risks and benefits

Participating in this study might offer potential benefits to you and future patients if the new NeuroSAFE technique proves to be more effective and leads to better quality of life outcomes compared to standard surgery. However, as with any medical procedure, there are potential risks associated with both surgical approaches, including those inherent to prostatectomy such as infection, bleeding, and the potential for urinary incontinence or erectile dysfunction. The study aims to understand and potentially reduce these risks. You have the right to withdraw from the study at any time without your medical care being affected.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • North Bristol NHS Trust
    Verified postcode
    Bristol, United Kingdom
  • NHS Greater Glasgow & Clyde
    Verified postcode
    Glasgow, United Kingdom
  • University College London Hospital
    Verified postcode
    London, United Kingdom
  • Nottingham University Hospitals
    Verified postcode
    Nottingham, United Kingdom
  • Sheffield Teaching Hospitals NHS Foundation Trust
    Verified postcode
    Sheffield, United Kingdom

Common questions

What is 'radical prostatectomy'?

It's a surgery where the entire prostate gland is removed, usually to treat prostate cancer that hasn't spread.

What is the NeuroSAFE procedure?

It's a new surgical technique being tested to potentially improve prostate cancer surgery outcomes, especially regarding preserving nerve function for bladder control and erections.

Why is 'nerve sparing' important?

Preserving the nerves near the prostate during surgery can help men maintain better bladder control and sexual function after the operation.

Will I definitely get the new NeuroSAFE technique if I join?

The study compares NeuroSAFE with standard robotic surgery, so you might receive either the new technique or the standard approach.

What does 'quality of life' mean in this study?

It refers to how the surgery affects aspects like your ability to control urine, sexual function, and overall well-being.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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