A clinical trial to test a rapid form of radiotherapy

What you need to know

• We are funding a team led by Dr Angela Pathmanathan, Prof Emma Hall, Prof Nicholas van As and Prof Suneil Jain to conduct a clinical trial using stereotactic body radiotherapy (SBRT), an advanced type of radiotherapy.
• SBRT delivers radiotherapy in larger doses, with far fewer visits than standard radiotherapy treatment.
• The team will investigate whether using SBRT to the prostate and nearby pelvic lymph nodes is as safe and more effective than SBRT treatment to the prostate only. As spread of cancer to the lymph nodes can be difficult to detect, treating both areas could reduce the risk of cancer returning in men with high risk disease.

An advanced form of radiotherapy to stop prostate cancer coming back

Men with high risk localised prostate cancer are at greater risk of their cancer coming back after initial treatment. Unfortunately, spread to nearby areas, such as the pelvic lymph nodes, is often difficult to detect in scans. We urgently need better treatments for these men to maximise their chance of a cure and minimise their risk of side-effects.

The team leading the study want to find out whether stereotactic body radiotherapy (SBRT), to the prostate and lymph nodes could offer a safe and more effective approach than current treatment options.

Prostate SBRT can be delivered in five visits – a significant reduction in attendances compared to standard prostate radiotherapy, typically given in 20 visits. This is beneficial for men and eases pressure on radiotherapy departments.

Targeting the prostate and the pelvic lymph nodes

Previous clinical trials by the team have shown that SBRT to the prostate is a safe treatment for men with low and intermediate risk localised disease. They now want to find out whether additional targeting of the lymph nodes, alongside the prostate, can further reduce the risk of prostate cancer returning in patients with high risk disease.

In this study, called PACE-NODES, over 500 men will receive SBRT treatment, either to the prostate and surrounding lymph nodes or to the prostate only. They will be closely monitored for side effects throughout the course of treatment and asked to report on their quality of life. The team will follow all patients up for at least 3 and half years to see which group has fewer men in whom prostate cancer returns.

Practice-changing results for men with high risk prostate cancer

By the end of the project, the team hope to demonstrate that giving SBRT to the prostate and pelvic lymph nodes is a safe and effective treatment. Together with data from previous trials, this trial could lead to an immediate change in clinical practice, giving men the option of a more convenient new treatment that reduces the risk of their cancer coming back.

How to get involved with this trial

This trial is looking for men to take part. You can read the information below to see if you may be suitable to take part in this study, and contact your medical team for full details on whether you can take part.

If you’d like support with deciding whether taking part in a clinical trial is right for you, you can speak to your medical team or contact our Specialist Nurses on 0800 074 8383.

Who can take part

You may be suitable to take part in this study if you have:

• You’ve had your prostate cancer confirmed with a biopsy
• You’re planning to have 12-36 months of hormone therapy (androgen deprivation therapy)
• You’ve been told your cancer is a high risk localised prostate cancer
• You’ve had an MRI of your pelvis
• You’ve had confirmation that your cancer hasn’t spread outside the prostate
• Your WHO performance status is 0-2

Who can’t take part

You would not be eligible to take part if you have:

• Your prostate cancer has spread outside the prostate
• Your PSA level is greater than 50 (or greater than 25 if you’re on 5-alpha reductase inhibitors), unless PET-CT imaging has confirmed your disease hasn’t spread
• You’ve had previous active treatment for prostate cancer
• You’re unable to have SBRT- for example if you have prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms

For full inclusion and exclusion criteria speak to your medical team.

Where the trial is taking place

• The James Cook University Hospital, Middlesborough

Speak to your medical team for the most up to date information on prostate cancer studies you may be eligible for.
For a general discussion about clinical trials, you may like to talk to our Specialist Nurses.

Grant information

Reference – MA-CT20-005    

Researcher – Professor Emma Hall and Dr Angela Pathmanathan 

Institution – Institute of Cancer Research

Award - £904,002.00