A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
This research looks at a new, faster way to deliver radiotherapy for men with prostate cancer that is considered high-risk but has not spread. It compares two different approaches: one group of men will receive special, focused radiotherapy (SBRT) only to their prostate gland. The other group will receive the same type of radiotherapy to both their prostate and the nearby lymph nodes (small glands that are part of the body's immune system). Both treatments are given in just 5 short visits. The study aims to see which treatment is safer and works best in preventing the cancer from returning, by carefully checking for any side effects and tracking the cancer over several years.
At a glance
What is this study about?
This study is investigating a modern type of radiotherapy called stereotactic body radiotherapy, or SBRT. This treatment is very precise and delivers strong bursts of radiation directly to the cancer. What's special about this study is that it's testing if SBRT, given in only 5 treatment sessions over about two weeks, can be an effective way to treat prostate cancer that is considered high-risk. High-risk means the cancer might be more likely to grow or spread quickly, even though it hasn't left the prostate gland yet. Being able to have treatment in just 5 visits could be a big advantage compared to traditional radiotherapy, which often requires many more sessions.
The main goal of this research is to compare two slightly different SBRT approaches. Half of the men taking part will have the SBRT treatment aimed only at their prostate gland. The other half will have the SBRT aimed at both their prostate gland and the nearby lymph nodes. Lymph nodes are small glands that can sometimes be where prostate cancer cells spread first. By treating them, doctors hope to reduce the chance of the cancer coming back.
The researchers will be carefully monitoring the men in the study for at least three and a half years. They want to see if treating the lymph nodes as well as the prostate makes a difference in preventing the cancer's return and if it's still a safe treatment. This will help them understand which approach is best for men with high-risk prostate cancer.
Key takeaways
- Compares two types of fast, precise radiotherapy (SBRT) for prostate cancer.
- Treatment involves only 5 visits over approximately two weeks.
- One group receives SBRT to the prostate, the other to prostate and lymph nodes.
- Aims to find the safest and most effective approach for high-risk prostate cancer.
- Study participants will be followed for at least three and a half years.
Who may be eligible?
To join this study, you need to be at least 18 years old and have had a recent diagnosis of prostate cancer that is considered high-risk. This means your cancer hasn't spread beyond your prostate but has certain features, like a higher Gleason score (which describes how aggressive the cancer cells look), a more advanced stage, or a higher PSA blood test result. You will likely also be getting hormone therapy (androgen deprivation therapy) for 12 to 36 months as part of your treatment.
Doctors will need to confirm your cancer diagnosis and make sure it hasn't spread to other parts of your body (like your bones or other organs) using scans such as MRI or PET-CT. You must also be generally well enough to take part in the study, which doctors assess using a standard health check.
There are also some reasons why you might not be able to join. For example, if your cancer has already spread to your lymph nodes or other parts of your body, or if you've had treatment for prostate cancer before. You also wouldn't be able to join if you have certain other health conditions, like severe bowel problems or if you've had radiotherapy to your pelvis in the past, or if previous scans show it wouldn't be safe to give you this type of radiotherapy.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a recent diagnosis of high-risk prostate cancer?
- Has your doctor confirmed your cancer has not spread beyond the prostate?
- Are you generally well and fit enough for treatment?
- Have you not had previous treatment for prostate cancer?
What does participation involve?
If you decide to take part in this study, you will receive radiotherapy in just 5 visits. Each visit will involve carefully planned SBRT treatment. Half of the participants will receive this treatment to their prostate only, and the other half will have it to both their prostate and surrounding lymph nodes. The main treatment phase will last about two weeks.
After your treatment, the study team will follow your health and cancer status for at least three and a half years. This will involve regular check-ups, scans, and blood tests to monitor for any side effects and to see how well the treatment worked in controlling your prostate cancer. The specific number and timing of these follow-up appointments will be clearly explained to you by the study team. You have the right to leave the study at any time.
Potential risks and benefits
Locations (42)
- Bon Secours Radiotherapy Cork in partnership with UPMC Hillman Cancer CentreVerified postcodeCork, Ireland· Recruiting
- St Lukes Radiation Oncology NetworkVerified postcodeDublin, Ireland· Recruiting
- Mid Western Radiation Oncology CentreVerified postcodeLimerick, Ireland· Recruiting
- Auckland HospitalVerified postcodeAuckland, New Zealand· Not yet recruiting
- James Cook University HospitalVerified postcodeMiddlesbrough, United Kingdom· Recruiting
- Worcestershire Acute Hospitals Nhs TrustVerified postcodeWorcester, United Kingdom· Recruiting
- Belfast City HospitalVerified postcodeBelfast, United Kingdom· Recruiting
- Bristol Haematology and Oncology CentreVerified postcodeBristol, United Kingdom· Recruiting
- West Suffolk NHS Foundation TrustVerified postcodeBury St Edmunds, United Kingdom· Recruiting
- Addenbrookes HospitalVerified postcodeCambridge, United Kingdom· Recruiting
- Velindre Cancer CentreVerified postcodeCardiff, United Kingdom· Not yet recruiting
- Gloucestershire Hospitals NHS Foundation TrustVerified postcodeCheltenham, United Kingdom· Recruiting
Common questions
What is SBRT?
SBRT stands for Stereotactic Body Radiotherapy. It's a special type of radiation treatment that delivers very high doses of radiation precisely to the cancer in a short amount of time, usually over just a few sessions.
What are lymph nodes and why might they be treated?
Lymph nodes are small, bean-shaped glands that are part of your body's immune system. When treating prostate cancer, doctors sometimes consider treating nearby lymph nodes because cancer cells can sometimes spread to them.
What is 'high-risk localised prostate cancer'?
This means the prostate cancer is still contained within the prostate gland, but it has features (like certain test results or how it looks under a microscope) that suggest it might be more aggressive or more likely to grow quickly if not treated effectively.
How long will the treatment take?
The actual radiotherapy treatment will be given in just 5 visits, typically over about two weeks.
Will I know if I'm getting prostate-only or prostate and lymph node treatment?
Because this is a study comparing two approaches, you will be randomly assigned to one of the two groups. The study team will explain how this works when you discuss joining the trial. You may not know which group you are in until after the study is complete, or you might be told at the time of randomisation, depending on the study design.
How to find out more
PACE-NODES Trial Manager
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.