Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Maria Ntessalen
+44 (0)1224 437263
elipse@abdn.ac.uk


Dr Krishna Narahari
+44 02920743318
krishna.narahari@wales.nhs.uk


Ms Seonaidh Cotton
+44 (0)1224 438178
s.c.cotton@abdn.ac.uk


Prof Rakesh Heer
-
r.heer@imperial.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Evaluation of the role of Lymphadenectomy In high-risk Prostate cancer SurgEry

Evaluation of the role of Lymphadenectomy In high-risk Prostate cancer SurgEry

Medical Conditions

Biopsy-proven clinically localised high-risk prostate cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2024 31 Aug 2026

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.


Adults aged 18 years old and over with biopsy-proven clinically localised high-risk prostate cancer who are suitable for radical prostatectomy

You can take part if:



You may not be able to take part if:


1. Hormone therapy within the 3 months prior to consent2. 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 treatment4. People without capacity


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North Bristol NHS Trust
    Southmead Hospital Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • University College London Hospitals NHS Foundation Trust
    250 Euston Road
    London
    NW1 2PG
  • Cardiff & Vale University Lhb
    Woodland House Maes-y-coed Road
    Cardiff
    CF14 4HH
  • Guy's and St Thomas' NHS Foundation Trust
    St Thomas' Hospital Westminster Bridge Road
    London
    SE1 7EH
  • Aberdeen Royal Infirmary
    Foresterhill Road
    Aberdeen
    AB25 2ZN
  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ
  • Lister Hospital
    Coreys Mill Lane
    Stevenage
    SG1 4AB
  • Royal Liverpool University Hospital
    Prescot Street
    Liverpool
    L7 8XP
  • St James University Hospital NHS Trust
    St James's University Hospital Gledow Wing Beckett Street
    Leeds
    LS9 7TF
  • Sunderland Royal Hospital
    Kayll Road
    Sunderland
    SR4 7TP
  • Norfolk & Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • University Hospital (coventry)
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Leicester General Hospital
    Gwendolen Road
    Leicester
    LE5 4PW
  • Charing Cross Hospital
    Fulham Palace Road
    London
    W6 8RF
  • Nottingham University Hospitals NHS Trust - City Campus
    Nottingham City Hospital Hucknall Road
    Nottingham
    NG5 1PB
  • Gartnavel Royal Hospital
    1055 Great Western Road
    Glasgow
    G12 0XH
  • New Cross Hospital Royal Wolverhampton
    Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Darent Valley Hospital
    Darenth Wood Road
    Dartford
    DA2 8AA
  • Lincoln County Hospital Laboratory
    Lincoln County Hospital Greetwell Road
    Lincoln
    LN2 5QY

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.

Prof Rakesh Heer
-
r.heer@imperial.ac.uk


Ms Seonaidh Cotton
+44 (0)1224 438178
s.c.cotton@abdn.ac.uk


Dr Krishna Narahari
+44 02920743318
krishna.narahari@wales.nhs.uk


Ms Maria Ntessalen
+44 (0)1224 437263
elipse@abdn.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cardiff and Vale University Health Board and funded by Health Technology Assessment Programme.




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Read full details for Trial ID: ISRCTN14434966

Or CPMS 63289

Last updated 16 September 2024

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