Outcomes of robotic assisted radical prostatectomy
Research type
Research Study
Full title
Outcomes of robotic assisted radical prostatectomy
IRAS ID
335340
Contact name
Ned Kinnear
Contact email
Sponsor organisation
Lister Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Prostate cancer is the second most common malignancy in males, after non-melanoma skin cancer. Globally, 1.4 million new cases are diagnosed annually, and this continues to rise. In the United Kingdom (UK), the annual incidence of prostate cancer is expected to exceed 60,000 patients by 2030. Approximately 45% of patients are diagnosed with localised intermediate risk disease and 25-55% of this group undergo surgery. Robotic-assisted laparoscopic prostatectomy (RALP) has become the preferred technique in most developed countries, chosen for 84% of men in the United States of America (USA) and 92% in the UK.
For patients RALP, intra-operative frozen section offers microscopically individualised dissection. However, to date no study from the UK has demonstrated that this achieves equivalent or superior functional outcomes, without compromising biochemical recurrence.
The study will enrol patients undergoing robotic assisted radical prostatectomy at Lister Hospital 01/01/2009 - 30/06/2023.
We will group patients by use of intra-operative frozen section (NeuroSAFE) or not (standard of care).
We hypothesise that NeuroSAFE patients will have equivalent biochemical recurrence free survival and superior functional outcomes (potency and continence).
Primary outcomes will be 1-year potency, continence and 1-year and 5-year biochemical recurrence.
Secondary outcomes: sub-group analyses will be performed, based on pre-operative and intra-operative factors (listed in protocol section 2.2.2), and histological factors, including surgical margin status.REC name
London - South East Research Ethics Committee
REC reference
23/PR/1210
Date of REC Opinion
1 Dec 2023
REC opinion
Further Information Favourable Opinion