A Multi-Centre, Randomised Control Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) in Men with Prostate Cancer
What is the purpose of this study?
We think that a new type of surgery called NeuroSAFE robotic assisted radical prostatectomy may be better for removing the prostate gland in patients with prostate cancer that has not spread to other parts of the body than the standard surgery. We think the new NeuroSAFE surgery may spare the nerves that run within the outer coverings of the prostate from damage and decrease the risk of leaving cancer cells behind. To test this, we will compare two planning methods which are used to plan nerve sparing during robotic prostatectomy. The first method involves a scan of the prostate called multiparametric magnetic resonance imaging (MRI). The other is a technique called NeuroSAFE. This technique involves, during the operation (whilst you are still asleep), an examination of the prostate under a microscope by a pathologist to see whether prostate cancer is touching the nerves. If it is not, the nerve is left in place. If it is, the nerve and cancer cells are removed. This is the only difference between the NeuroSAFE technique radical prostatectomy and current standard care. We will also evaluate the use of novel imaging techniques such as confocal microscopy in evaluating surgical margins during surgery.
Why is this research being done?
Prostate cancer that has not spread outside the prostate can usually be cured by having surgery to remove the prostate gland. This surgery is called robotic assisted radical prostatectomy. However, some patients who undergo this surgery may develop urinary incontinence due to damage to the internal involuntary sphincter and erectile dysfunction due to damage of the nerves that run within the outer coverings of the prostate. Nerve sparing surgery during RARP aims to spare these nerves to preserve quality of life and erectile function. However, the nerve sparing surgery may risk leaving cancer cells behind meaning that these patients may need extra treatment with radiotherapy. The NeuroSAFE technique is designed to minimise side effects of the surgery without compromising cancer care. We plan to evaluate whether using NeuroSAFE is effective. This trial will evaluate, through a large scale multicentre randomised controlled study, the effects of use of the NeuroSAFE technique alongside radical prostatectomy in terms of improving potency, urinary continence, quality of life as well as preserving cancer control, and compare this to current standard radical prostatectomy. A full evaluation of the cost effectiveness of the technique (informing about value for money for the NHS) will also be incorporated.
What are the benefits of taking part in the study?
By taking part patients may benefit from seeing the same research nurse or trial practitioner at each of the assessment visits. Patients may also benefit from a more thorough review of their recovery after surgery. Information we get from this study may help us to treat patients with prostate cancers more effectively in the future.
Furthermore, patients will help in answering and understanding important questions such as:
- To understand if the NeuroSAFE technique reduces side effects from radical prostatectomy
- To ensure that the NeuroSAFE technique does not result in worse cancer outcomes at 5 years
- To understand if the NeuroSAFE technique improves the quality of life and continence of men
- To investigate the cost of health resource use after radical prostatectomy for men who have had a NeuroSAFE radical prostatectomy and compare it to those who have had a standard radical prostatectomy
Who is being included in the study?
We plan to recruit a total of 404 men from 5 separate NHS sites (University College London Hospital, Southmead Hospital in Bristol, Sheffield Teaching Hospitals, Greater Glasgow and Clyde & Nottingham University Hospitals). This is a Phase III Surgical study – Fully powered interventional, single blinded, multi-centre, randomised controlled trial. Patients are randomised 1:1 between NeuroSAFE and MRI planned RARP. The primary endpoint is the potency of men evaluated by validated PROMS questionnaire 1 year after surgery.
What is the current status of the study?
The NeuroSAFE PROOF study is not recruiting but is in follow-up.
Who is carrying out the study?
The NeuroSAFE PROOF study is being conducted by University College London, who is the sponsor of the research. The study is funded by J P Moulton Foundation Trust and the NIHR Research for Patient Benefit programme (RfPB).
If I have any questions, who can I contact?
If you have any questions, please contact your hospital medical team. You can also contact us by email at ncita.neurosafe@ucl.ac.uk
For more information see the NeuroSAFE PROOF study website: https://www.neurosafeproof.com/
View also the NeuroSAFE PROOF study record on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03317990