Evaluation of the role of Lymphadenectomy In high-risk Prostate cancer SurgEry
| ISRCTN | ISRCTN14434966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14434966 |
| IRAS number | 329888 |
| Secondary identifying numbers | CPMS 63289, IRAS 329888, NIHR152686 |
- Submission date
- 02/08/2024
- Registration date
- 06/08/2024
- Last edited
- 16/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Every year in the UK, nearly 50,000 people are diagnosed with prostate cancer and over 10,000 men die from it. Prostate cancer that has not spread elsewhere in the body but is at risk of doing so is referred to as high-risk localised prostate cancer. Established treatment options for high-risk prostate cancer are surgery and radiotherapy. In the UK, 4000 patients a year undergo surgery for high-risk prostate cancer. When surgeons operate on men with high-risk prostate cancer, 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 the 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. The study team surveyed UK surgeons and found variable practice with 35% of eligible patients getting lymph node excision. Surgeons stated that 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. This clinical trial aims to compare the two treatments in terms of their effect over 3 years on, prostate cancer recurrence, quality of life, complication rates, survival and use of NHS resources. Everyone who takes part will have an equal chance of either having their lymph nodes removed or not during their prostate cancer PCa surgery. The study will recruit 1080 patients from 25 hospitals across the UK.
Who can participate?
Adults aged 18 years old and over with biopsy-proven clinically localised high-risk prostate cancer who are suitable for radical prostatectomy
What does the study involve?
Adults who consent to participate in ELIPSE will be randomly allocated to one of the two types of surgery mentioned above. After the surgery, they will be sent participants questionnaires for up to 36 months to collect information on several things, including cancer recurrence, harms, quality of life, time to return to normal activities, and costs. Further information will also be collected from their routine follow-up that is recorded in their medical records.
What are the possible benefits and risks of participating?
Participants may not benefit personally from taking part but, by taking part, will help inform the treatment of future patients who need to have radical prostatectomy. The results of the ELIPSE study will help doctors, surgeons, patients and health services decision-makers understand whether it is better to remove lymph nodes during a radical prostatectomy, or not. Both types of surgery are already being used in the NHS to treat patients. There are risks associated with all surgical procedures but there should be no additional risk in taking part in the study.
Where is the study run from?
The Cardiff and Vale University Health Board are leading the study. The day-to-day management of the study is being led by the University of Aberdeen. Hospital sites across the UK will take part.
When is the study starting and how long is it expected to run for?
February 2024 to August 2029
Who is funding the study?
The National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme
Who is the main contact?
Maria Ntessalen, elipse@abdn.ac.uk
Contact information
Principal Investigator
Urology Department, Cardiff and Vale University Health Board, Heath Park Way
Cardiff
CF14 4XW
United Kingdom
 ORCID ID |
0000-0003-0257-7033 |
|---|---|
| Phone | +44 02920743318 |
| krishna.narahari@wales.nhs.uk |
Principal Investigator
Division of Surgery, Imperial College London, Hammersmith House, Hammersmith Campus
London
W12 0NN
United Kingdom
| ORCID ID |
0000-0003-1952-7462 |
|---|---|
| r.heer@imperial.ac.uk |
Public
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
| ORCID ID |
0000-0002-8178-8666 |
|---|---|
| Phone | +44 (0)1224 437263 |
| elipse@abdn.ac.uk |
Public
Centre for Healthcare Randomised Trials (CHaRT), University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
| ORCID ID |
0000-0002-7883-0608 |
|---|---|
| Phone | +44 (0)1224 438178 |
| s.c.cotton@abdn.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Internet/virtual, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at: https://w3.abdn.ac.uk/hsru/ELIPSE/Public/Public/index.cshtml |
| Scientific 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 |
| Study acronym | ELIPSE |
| Study hypothesis | Radical prostatectomy plus pelvic lymph node dissection offers better cancer control than radical prostatectomy alone in patients undergoing surgery for high-risk prostate cancer. |
| Ethics approval(s) |
Approved 04/07/2024, West of Scotland REC 5 (NHS Greater Glasgow & Clyde, West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 24/WS/0075 |
| Condition | Biopsy-proven clinically localised high-risk prostate cancer |
| Intervention | Participants will be identified through screening in local and regional specialist multi-disciplinary teams. Adult males with biopsy-proven clinically localised high-risk PCa, where the local multi-disciplinary review has identified them as suitable for radical prostatectomy, with negative staging imaging and who are able and willing to give informed consent and participate in study procedures will be considered for inclusion. Potential participants who have had hormone therapy within the 3 months before consent will be excluded from the study. Eligible patients will be provided with a Participant Information Leaflet (PIL) containing information about the study. If interested the patient will have the opportunity to discuss the surgical options and ask any questions about the study with a member of the clinical team, either face-to-face or virtually. Eligible patients can discuss the study with other NHS team members, their GP, as well as family and friends before deciding whether to participate in the trial. If the participant decides to give their consent, they will be asked to sign a consent form either during a hospital visit or at home (and return through the post). Participants will be asked to complete a baseline questionnaire which asks about their generic and prostate-cancer-specific quality of life. Where consent is by post, this may be completed at the same time and posted back with the consent. The local research team will complete a baseline case report form collecting data on age, sex assigned at birth, ethnicity, height, weight, postcode, medical history, smoking status, Gleason grade and stage. The results of the prostate-specific antigen (PSA) test considered by the MDT will also be recorded. Participants will be randomised as close to the time of surgery as is feasible to receive either radical prostatectomy (RP) with pelvic lymph node dissection (PLND) or radical prostatectomy alone. The procedure will be undertaken as per standard NHS care. Blinding of surgeons is not possible and participants will be informed of their treatment allocation. The local research team will collect information about the surgical procedure, any intraoperative complications and pathology results from medical records (or in real-time, as applicable). The date and results of all post-surgery PSA tests up to 3 years will be recorded by the research team from laboratory records. 3 months after surgery, the local research team will collect information from the medical records to complete the Comprehensive Complications Index, recording any complications following surgery. At 36 months post-surgery the local research team will review the participant's medical notes to identify any further related use of NHS resources, recurrence from routine scans and absence of demonstrable metastasis. Participants will also be asked to complete questionnaires by post, email or text (as per participant preference) at 3 months after surgery and 12, 24 and 36 months after surgery to collect information (at the relevant time point) on quality of life, quality of recovery, NHS resource use and participant costs, time and travel and to report any complications and further treatments. Around 36 months, the team at the site will also contact the participants by phone to find out if they had any additional visits to hospitals that the local team was not aware of. Outcomes will be compared between radical prostatectomy (RP) with pelvic lymph node dissection (PLND) or radical prostatectomy alone. Participants are free to withdraw consent from the study at any time point. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Cancer recurrence, defined as prostate-specific antigen (PSA) recurrence/persistence with two consecutive measures ≥0.2ng/ml and/or disease progression (eg metastatic disease) and/or need for further prostate cancer treatment and/or prostate cancer-specific death and is assessed over 3 years. 2. Economic outcome measured as incremental cost per QALY gained at 3 years |
| Secondary outcome measures | 1. Harms (complications and re-intervention rates) measured using CLASSIntra during surgery, the Comprehensive Complications Index at 3 months, from medical records up to 3 years, and questionnaires at 12, 24 and 36 months 2. Complete excision of the primary prostate tumour measured using the surgical margins after surgery 3. Metastasis-free survival measured using imaging from routine follow-up 4. Health-related quality of life measured using EPIC 26 and EQ-5D-5L questionnaires at baseline, and 3, 12, 18, 24 and 36 months 5. Time to return to normal activities measured using a questionnaire at 3 months 6. Indirect costs due to productivity losses measured using a questionnaire at 12, 24 and 26 months 7. Costs to participants measured using a questionnaire at 12, 24 and 36 months |
| Overall study start date | 01/02/2024 |
| Overall study end date | 31/08/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 1080; UK Sample Size: 1080 |
| Participant inclusion criteria | 1. Adults ≥18 years 2. Biopsy-proven clinically localised high-risk PCa 3. Local multi-disciplinary review identifying those cases thought be suitable for RP; with negative staging imaging (as per local standard of care) 4. Able and willing to give informed consent to participate and to participate in study procedures |
| Participant exclusion criteria | 1. Hormone therapy within the 3 months prior to consent 2. Previous radical treatment for PCa (radical treatment includes radical prostatectomy and/or radiotherapy and/or focal therapy [eg cryotherapy or HIFU]) 3. Unsuitable for surgical treatment 4. People without capacity |
| Recruitment start date | 01/09/2024 |
| Recruitment end date | 31/08/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Liverpool
L7 8XP
United Kingdom
Glasgow
G12 0XH
United Kingdom
Gledow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Coventry
CV2 2DX
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
W6 8RF
United Kingdom
Dartford
DA2 8AA
United Kingdom
Greetwell Road
Lincoln
LN2 5QY
United Kingdom
Sheffield
S10 2JF
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
London
NW1 2PG
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Leicester
LE5 4PW
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Cardiff Joint Research Office, 2nd Floor, Lakeside Building, Heath Park
Cardiff
CF14 4XW
Wales
United Kingdom
| Phone | +44 02921846126 |
|---|---|
| research.governance@wales.nhs.uk | |
| Website | https://cavuhb.nhs.wales/ |
"ROR" |
https://ror.org/0489f6q08 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2031 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 05/07/2024 | 05/08/2024 | No | No |
Additional files
Editorial Notes
16/09/2024: The following study participating centres were added: St James University Hospital NHS Trust, Aberdeen Royal Infirmary, University Hospital (Coventry), Guy's and St Thomas' NHS Foundation Trust, Charing Cross Hospital, Darent Valley Hospital, Lincoln County Hospital Laboratory, Royal Hallamshire Hospital, Nottingham University Hospitals NHS Trust - City Campus, North Bristol NHS Trust, University College London Hospitals NHS Foundation Trust, Lister Hospital, Sunderland Royal Hospital, Norfolk & Norwich University Hospital, Leicester General Hospital, New Cross Hospital Royal Wolverhampton, and Addenbrookes.
02/08/2024: Study's existence confirmed by the NIHR.
