ELIPSE
Research type
Research Study
Full title
A randomised controlled trial comparing the clinical and cost-effectiveness of lymph node removal in patients undergoing curative surgery for localised high-risk Prostate Cancer.
IRAS ID
329888
Contact name
Krishna Narahari
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Duration of Study in the UK
5 years, 11 months, 31 days
Research summary
Every year in the UK, nearly 50,000 people are diagnosed with prostate cancer (PCa) and over 10,000 men die from it. PCa that has not spread elsewhere in the body but is at risk of doing so is referred to as high-risk localised PCa. Established treatment options for high-risk PCa are surgery and radiotherapy. In the UK, 4000 patients a year undergo surgery for high-risk PCa. When surgeons operate on men with high-risk PCa, they remove the entire prostate gland and, in some cases, also remove the nearby lymph nodes (an immune tissue that forms the early landing sites for cancer spread) in a surgery called pelvic lymph node dissection (PLND). It is thought that PLND gives better cancer clearance and reduces recurrence, which is seen in 30-50% of men with high-risk disease. However, complications can arise from PLND. These complications may reduce quality of life, and along with the increased surgical time required, lymph node surgery in addition to removing the prostate might result in additional costs to the NHS.
We surveyed UK surgeons and found variable practice with 35% of eligible patients getting lymph node excision. Surgeons told us the current evidence was not good enough to inform decisions about whether it was beneficial to do a lymph node excision knowing that there are potential harms, and a clinical trial comparing lymph node excision to no lymph node excision was urgently required.
We plan to conduct a clinical trial to compare the two treatments in terms of their effect over 3 years on, PCa recurrence, quality of life, complication rates, survival and use of NHS resources. Everyone that takes part will have an equal chance of either having their lymph nodes removed or not during their PCa surgery. The study will recruit 1080 patients from 25 hospitals across the UK.
REC name
West of Scotland REC 5
REC reference
24/WS/0075
Date of REC Opinion
4 Jul 2024
REC opinion
Further Information Favourable Opinion