A study looking at PET-CT scan in men with prostate cancer and a DNA gene mutation (GENPET)
Cancer type:
Status:
Phase:
This study is looking at whether a type of PET-CT scan shows how much prostate cancer is present in men who have a 
Repair change ().
This study is open to men with prostate cancer who are going to the Royal Marsden NHS Foundation Trust and have a gene change in one of the following genes:
BRCA1 BRCA2 - MSH2
- MSH6
- MLH1
- PMS2
- CHEK2
- PALB2
- ATM
More about this trial
Research has shown that prostate cancer can be more aggressive in men who have changes in certain DNA Repair genes. So it is important they have the best treatment for their stage of cancer.
In this study researchers are using a with a . The radioactive 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 you are a patient at the Royal Marsden Hospital. You are at least 18 years old and have prostate cancer with a change (mutation) in one of the following DNA Repair genes:
- BRCA1
- BRCA2
- MSH2
- MSH6
- MLH1
- PMS2
- CHEK2
- PALB2
- ATM
Your doctor will know if your cancer has one of these gene changes.
And you are in one of the following situations:
- 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 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 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
non melanoma 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)
Trial design
The researchers need at least 50 men to join this study.
You have a PET-CT scan with the radioactive tracer.
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 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.
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 a second specialist reviews your scans. 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.
Hospital visits
All men with a DNA Repair gene mutation who are going to the Royal Marsden Hospital have this type of PET-CT scan. The other scans are a part of your routine care. So you have no extra visits if you take part in this study.
Side effects
There are no side effects from taking part in this study.
We have information about having a:
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Rosalind Eeles
Supported by
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Royal Marsden Hospital NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
