Study Title: A single blinded, multi-centre, feasibility study to evaluate the ability to randomise men with prostate cancer into a trial comparing NeuroSAFE Robotic assisted radical prostatectomy (RALP) to standard Robotic assisted radical prostatectomy (RALP).
Short Title: NeuroSAFE PROOF
Localised prostate cancer is common but can usually be cured with surgery, however, this often leads to a loss of erections and urinary incontinence due to nerve damage. Nerve sparing, where the outer layers of the prostate are peeled off, increases post-operative potency, but increases the risk of cancer being left behind and the need for radiotherapy, which renders the men impotent, even if they had nerve sparing surgery. A new technique called NeuroSAFE has been developed to promote nerve sparing without compromising cancer control. With the NeuroSAFE technique, during surgery, a pathologist examines the prostate near the nerves to check for exposed cancer. If cancer is found, the nerve tissue is removed so the recurrence risk is similar to when cancer cells are not exposed.
This study will compare NeuroSAFE with current UK practice (non- NeuroSAFE, where nerve sparing is based on an MRI scan and biopsy results and clinical examination before the operation, rather than an examination by a pathologist during the operation). Men will be randomly allocated, to either NeuroSAFE or robotic prostatectomy without NeuroSAFE. The main measure of effectiveness will be the proportion of men who have erections and cancer control at 1 year post surgery. We will also evaluate quality of life, including patient recorded outcome measures and analyse the cost/benefit of the procedure.
This study is needed because we are treating larger and more aggressive cancers. Information about nerve sparing is based on limited evidence from studies where the risk of treatment failure is lower. Adoption of nerve sparing without scientific evaluation puts UK men at risk of disease recurrence and extra treatment.
Sponsor: University College London (UCL)
Supported by: NIHR Research for Patient Benefit
ClinicalTrials.gov Identifier: NCT03317990