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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.
Stephanie
Burnett
pace-nodes-icrctsu@icr.ac.uk
Dr
Nicholas
Van As
nicholas.vanas@rmh.nhs.uk
Malignant neoplasms of male genital organs
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.
This study will look at the safety of curative radiotherapy to the prostate and lymph glands given in 5 visits, in men with high risk localised prostate cancer.
The purpose of the research is to test an advanced type of external beam radiotherapy called stereotactic body radiotherapy (also known as SBRT) in 536 participants with high risk localised prostate cancer (that is, prostate cancer that has not spread beyond the prostate gland but is at high risk of growing quickly or spreading). Importantly, this treatment delivers a potentially curative dose of radiotherapy in only 5 treatments over two weeks. Half the participants in the trial will receive radiotherapy to the prostate, the other half will have radiotherapy to the prostate as well as the surrounding lymph nodes. We will follow patients in the trial for at least three and half years to see which treatment is best. We will be looking at whether it is safe to give this treatment by reviewing any side-effects that occur and also assessing whether giving SBRT to the lymph nodes as well as the prostate reduces the chance of prostate cancer returning.
The treatment will take place at NHS radiotherapy centres that are experienced in giving SBRT and radiotherapy to the pelvic nodes, and have been quality assured to deliver these treatments.
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:
Interventional type: Radiotherapy;
You can take part if:
You may not be able to take part if:
1. N1 or M1 disease 2. PSA > 50ng/ml (or > 25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease 3. Previous active treatment for prostate cancer 4. Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded. 5. Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications 6. Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult. 7. Patients who have had chemotherapy within 6 weeks of the start of radiotherapy. 8. Life expectancy < 5 years
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Institute of Cancer Research: Royal Cancer Hospital and funded by Prostate Cancer UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 52562
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
