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Contact Information:

Dr Ann Henry
+44 (0)113 2067630
ann.henry2@nhs.net


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

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Be Part of Research - Trial Details - Retreating localised prostate cancer with either repeat radiotherapy or brachytherapy
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Retreating localised prostate cancer with either repeat radiotherapy or brachytherapy

Recruiting

Open to: Male

Age: Adult

Manchester Leeds Stevenage

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.



Background and study aims
Prostate cancer is the most common UK male cancer. Radiotherapy is a type of cancer treatment that involves using radiation energy to kill cancer cells. The two ways to deliver radiation are from a machine outside the body (external beam radiation) or from internal sources placed within the body (brachytherapy) while the patient is asleep (requires a general anaesthetic).

Despite these treatments, in some patients, the cancer can come back and most of these cancers will come back within the prostate gland itself, which is called a local recurrence. Current research suggests treating the recurrence with a second course of radiation given using either brachytherapy or external beam may be better than other options (such as surgery) as there are fewer side effects. Brachytherapy and external beam radiotherapy for recurrence have not been directly compared and the side effects people experience after treatment have not been fully described.

External beam radiation can now be delivered so that more intense radiation doses are directed to the cancer in a more accurate way by using daily imaging. This new treatment is called ultra-hypofractionated or stereotactic ablative radiotherapy (SABR). Although it has been widely used for other indications, we do not know how effective it is for treating prostate cancer recurrence. We also have limited information on treatment side effects.

We want to check if participants are happy to be randomised to either treatment to see if a larger study may be possible. We also want to assess how the radiation treatment impacts on people’s long term quality of life by regular follow-ups and questionnaires. This means future patients will have better information when making treatment choices.

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 Jul 2022 30 Jul 2024

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36351720/ (added 10/11/2022)

Participants will receive one of two radiation treatments, either HDR Brachytherapy (HDR-BT) (standard of care) or ultra-hypofractioned external beam radiotherapy (EBRT). The treatment that a participant will receive will be decided at random (like tossing a coin).

For the participants receiving HDR-BT treatment, this will involve two separate visits to the hospital, as the treatment is carried out in two stages. These visits will be about 2 weeks apart. As each treatment requires a general anaesthetic, participants may need to stay in the hospital overnight after the treatment for observation.

For the participants receiving ultra-hypofractionated EBRT treatment, the participant will visit the hospital once for a planning CT scan and then on 5 separate occasions within a 2 week period to receive the radiation treatment. No general anaesthetic will be required for these treatment sessions. The participant will come for their treatment and leave on the same day.

Participants will be followed up by the study team for evaluation at 1, 3, 6, 12, and 24 months after treatment is completed.


Participation is by invitation only. Adult men with locally recurrent prostate cancer proven by biopsy will be invited to participate in the study.

You can take part if:



You may not be able to take part if:


1. Not compliant with any inclusion criteria2. Do not have a prostate biopsy confirming locally recurrent prostate cancer or who are unfit for a prostate biopsy3. Unfit for a general anaesthetic due to other comorbidities4. Contraindications to MRI5. Clinical or radiological evidence of metastatic prostate disease6. Medical or psychiatric condition that impairs their ability to give informed consent


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

  • The Christie NHS Foundation Trust
    550 Wilmslow Road Withington
    Manchester
    M20 4BX
  • Leeds Teaching Hospitals NHS Trust
    St. James's University Hospital Beckett Street
    Leeds
    LS9 7TF
  • East and North Hertfordshire NHS Trust
    Lister Hospital Coreys Mill Lane
    Stevenage
    SG1 4AB

We hope that the treatments will help participants and give them a better chance to get rid of their cancer. However, this cannot be guaranteed. The information we get from this study may help us to improve the future treatment of patients with prostate cancer as we will understand better the side effects so we can tailor treatments more effectively to patients.
By participating in this study, participants may have some extra tests, some of which are optional but others such as the MRI scan are required. Radiotherapy treatment, both external beam radiation treatment (EBRT) and brachytherapy, can cause side effects because of the healthy tissue around the cancer being exposed to the radiation. Bowel side effects (more common with EBRT) include increase in the frequency and urgency of bowel movements, lower abdominal discomfort, passing of mucus and bleeding from the back passage. Bladder side effects (more common with brachytherapy) include urinating more frequently and/or urgently, the need for a catheter (1 in 10 patients). Narrowing of the urethra, known as a stricture, can occur in 2 out of ten in the long term. In addition, fewer than 2 out of 10 men will experience slight blood loss whilst urinating during and after radiotherapy.

Dr Ann Henry
+44 (0)113 2067630
ann.henry2@nhs.net



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 University of Leeds and funded by Cancer Research UK.



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What will you do next?
Read full details for Trial ID: ISRCTN12238218

Or CPMS 51466

Last updated 08 April 2024

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