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A study looking at PET-CT scan in men with prostate cancer and the BRCA gene mutation (GENPET)
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This study is looking at whether a type of PET-CT scan shows how much prostate cancer is present in men who have the BRCA 1 or 2 gene mutation.
More about this trial
In this study researchers are using a PET-CT scan with a radioactive drug tracer. The radioactive drug tracer is given as an injection as part of the scan. It travels in the bloodstream and is taken up by areas in the body where there may be cancer present. The researchers want to see if it is better at showing if the cancer has spread elsewhere in the body such as to the lymph nodes, lungs, liver or bones.
They will compare it with the results of more commonly used scans such as
- MRI scan
- CT scan
- Bone scan
It is unlikely that taking part in this study will change any treatment you have.
Researchers hope that this type of PET-CT scan can produce a more accurate picture of cancer. If so, this could lead to more targeted treatments in the future.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply. You are a patient at the Royal Marsden Hospital and
- You have prostate cancer and you have an inherited (germline) BRCA 1 or 2 gene mutation and 1 of the following applies.
- You are newly diagnosed with prostate cancer
- You were treated with radical surgery or radiotherapy more than 6 months ago and your blood tests show your cancer might be growing and you are not currently having hormone treatment or chemotherapy
- You are on active surveillance and your PSA is doubling every 6 months or less, or a scan or tissue sample (biopsy) shows your cancer might be growing
- You are aged 18 or older
You cannot join this study if any of these apply. You
- Have prostate cancer that has spread outside of the prostate gland (locally advanced or metastatic prostate cancer)
- Have had anti cancer treatment in the last 6 months
- Are having any experimental drug treatment
- Are taking steroids
- Have had any other type of cancer in the last 5 years apart from basal cell or squamous cell skin cancer
- Have had certain inflammatory conditions such as inflammatory bowel disease or sarcoidosis
- Have had certain infections such as tuberculosis (TB)
- Are not able to have an MRI scan for any reason such as having a pacemaker, metal surgical clips, or a fear of closed spaces (claustrophobia)
The researchers need 71 men to join this study.
You have a PET-CT scan with the radioactive tracer. If you have not had one done recently you also have
- an MRI or CT scan
- a bone scan
The researchers then compare the results of the scans. You would have these scans as part of your routine care whether you are in this study or not. The only difference is that the scans are reviewed by a second specialist. This is usual practice in clinical studies.
The researchers ask you if they can look at your medical records 3 and 5 years after you have the scans. This is so they can see what has happened with your prostate cancer.
All men with a BRCA gene mutation who are going to the Royal Marsden Hospital have this type of PET-CT scan and the other scans as part of their routine care. So you have no extra visits if you take part in this study.
The PET-CT scan takes approximately 35 minutes. You have a small tube (cannula) put into one of the veins in the back of your hand or arm. Then you have the radioactive tracer as an injection through the tube.
The tracer travels in the bloodstream and is taken up by areas of the body where there may be cancer. This then shows up on the scan. The tracer only remains in your body for a few hours.
How to join a clinical trial
Professor Rosalind Eeles
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden Hospital NHS Foundation Trust