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 Shama Hassan
+44 (0)20 8722 4183
pearls-icrctsu@icr.ac.uk


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - PEARLS - a trial of radiotherapy in newly-diagnosed patients with lymph node positive prostate cancer

PEARLS - a trial of radiotherapy in newly-diagnosed patients with lymph node positive prostate cancer

Medical Conditions

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.



Background and study aims
Prostate cancer is the most common cancer in men in the UK. It usually develops slowly, so there may be no signs for many years.
PEARLS aims to improve patient outcomes by treating patients whose cancer has spread to the lymph nodes with radiotherapy to an extended area than is currently used. The investigators think that by extending radiation to cover a wider area where recurrences can often occur may improve control of the cancer. There is currently no standard management for prostate cancer patients who present at diagnosis with cancer having spread to the lymph nodes in the abdomen. Previous studies have indicated that it is safe to treat the prostate and pelvic areas with radiotherapy. There have been no recent studies using modern radiotherapy technology to treat larger areas within the abdomen.

PEARLS will assess the differences in side effects for patients treated with standard or an extended radiotherapy area to make sure these are acceptable and if they are, we will include more patients in the study to see if the extended radiotherapy treatment helps to control the cancer better.

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:

30 Jun 2021 31 Dec 2027

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36238579/ (added 04/06/2024)

An interim review of safety in the first 150 patients will permit early stopping of the trial if toxicity associated with the extended radiotherapy area is unacceptable.

Patients will be randomised based on the extent of disease in their lymph nodes to either a standard area or an extended area including the lymph nodes in the abdomen. Radiotherapy will involve treatment over 20 fractions for all patients. Patients will be followed up at regular intervals.

Patients will be asked to complete quality of life questionnaires. In addition, patients may be asked to take part in optional sub-studies running within PEARLS, which will include donation of blood samples, stool samples and an additional PSMA PET-CT scan 6 months after the end of radiotherapy and recurrence.


Adult (18+ years) male patients with lymph node positive prostate cancer.

You can take part if:



You may not be able to take part if:


1. Prior radiotherapy to the prostate or pelvis; prior bilateral orchiectomy; radical prostatectomy.2. For those patients who have received docetaxel chemotherapy or are receiving androgen receptor targeted therapy, there should be no ongoing CTCAE grade 2 or greater GI toxicity relating to this systemic therapy.3. Medical conditions (non-prostate cancer related) expected to limit life expectancy to < 5 years.4. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult.5. Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, intractable urinary symptoms, previous colorectal surgery.6. Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin or small renal masses under surveillance), or if previous malignancy is expected to significantly compromise 5 year survival.7. Any other contraindication to external beam radiotherapy to the para-aortic and/or pelvic region.


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

  • University College London Hospital
    University College London Hospitals NHS Foundation Trust 250 Euston Road
    London
    NW1 2PG
  • Derriford Hospital
    Derriford Road Crownhill
    Plymouth
    PL6 8DH
  • The Royal Marsden Hospital
    Fulham Road Chelsea
    London
    SW3 6JJ
  • Walsgrave General Hospital
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Lister Hospital
    Coreys Mill Lane Hertfordshire
    Stevenage
    SG1 4AB
  • Addenbrooke's Hospital
    Cambridge University Hospitals NHS Foundation Trust Hills Road
    Cambridge
    CB2 0QQ
  • Maidstone Hospital
    Maidstone and Tunbridge Wells NHS Trust Hermitage Lane
    Maidstone
    ME16 9QQ
  • St Thomas’ Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Queen Elizabeth Hospital Birmingham
    University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Bristol Royal Infirmary
    University Hospitals Bristol and Weston NHS Foudnation Trust Marlborough Street
    Bristol
    BS1 3NU
  • John Radcliffe Hopsital
    Headley Way
    Oxford
    OX3 9DU
  • Freeman Hospital
    Newcastle Upon Tyne Hospital Trust Freeman Road High Heaton
    Newcastle
    NE7 7DN
  • The Christie Hospital
    Wilmslow Road Withington
    Manchester
    M20 4BX
  • Clatterbridge Cancer Centre
    Clatterbridge Road Bebington
    Wirral
    CH63 4JY

All patients in the trial will be treated with high quality technical advanced radiotherapy designed by a group of leading experts in the field of prostate radiotherapy. It is hoped that there will be improved tumour control if radiotherapy of the para-aortic lymph nodes is more effective than just treating the prostate and pelvic lymph nodes. Improved tumour control might lead to a lower use of treatments for recurrent cancer and improved survival. The information we get from this study will help us to improve the future treatment of patients with prostate cancer. Although by taking part in the study, patients may not directly benefit, it will help to answer these questions and hopefully improve treatment for prostate cancer patients in the future.
Patients may receive an intravenous contrast agent to help design their radiotherapy and they are asked to let the radiographer know if they have ever had any problems after contrast injections. The para-aortic lymph node radiotherapy may have an increased risk of side effects (nausea, loose motions and diarrhoea), because more bowel will be exposed to radiotherapy compared to prostate/pelvic node radiotherapy. The investigators will try to minimise these risks, but treating larger areas can have more side effects.


The study is sponsored by Institute of Cancer Research and funded by Cancer Research UK.





We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN36344989

Or CPMS 48429

Last updated 04 June 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.