A study to find out if looking at gene changes could be part of prostate cancer screening (PROFILE study)
Cancer type:
Status:
Phase:
This study is looking at the role of gene changes in screening for prostate cancer. It is for men aged 40 to 69 who:
- who have a family history of prostate cancer
- are of Black African or Black African-Caribbean descent
- have a
gene 
change (mutation ) that could mean they are at a higher risk of developing prostate cancer
This study follows on from a pilot study that looked at whether this would be a useful area of research. You can read about the PROFILE pilot study.
More about this trial
A family history means that you have someone in your family who has cancer. We know that a family history of prostate cancer increases your risk. Particularly so if the diagnosis of your relative was before the age of 70. We also know that men of Black African and Black African-Caribbean descent have an increased risk of developing prostate cancer.
This study is looking to see if men in these 2 groups are more likely to develop prostate cancer if certain gene changes are present.
Men taking part will have prostate cancer screening tests. They may also have scans, some prostate tissue samples taken (a ) as well as blood and urine tests. From this researchers build a picture (a genetic profile) of each man’s gene changes. They will also look for other for prostate cancer.
The researchers want to find out if knowing more about genetic changes can improve prostate cancer screening for men who are at an increased risk.
Who can enter
You can enter this trial if you are a man and there is a family history of prostate cancer in one of the following situations. You have:
- a father, brother or son who had a prostate cancer diagnosis under the age of 70
- 2 relatives on the same side of the family diagnosed with prostate cancer. And at least one was diagnosed under 70 years old.
- 3 relatives on the same side of the family diagnosed with prostate cancer at any age
Or you are of Black African or Black African-Caribbean descent and
- both your parents and all 4 grandparents are of the same origin
You can also join if you have a change () in a gene or that means you might be at a higher risk of developing prostate cancer.
All men taking part need to be:
- well enough to be up and about for at least half the day but might not be able to work (performance status 0, 1 or 2)
- able to take full part in the study
- aged 40 to 69
You cannot enter this study if you:
- have had prostate cancer
- have any other cancer that your specialist thinks may become much worse in the next 5 years
- have had a sample of prostate tissue taken in the last year (a prostate biopsy)
- are not able to have a prostate biopsy, for example you are taking a blood thinning medication such as warfarin or clopidogrel as this makes it more risky to have a biopsy
- have diabetes that isn't well controlled or a disease that affects the heart or blood vessels (cardivascular disease) as this makes it more risky to have a biopsy
- have a lung disease
- have a body mass index (BMI) that is 40 or above
- have a body mass index that is 35 or above and you also have other health conditions that mean you can't take part in the study. Your doctor can tell you more about this.
- are unable to have an MRI scan for any reason such as having a pacemaker, cochlear implant, any metal clips in your body or you can't be in small spaces (claustrophobia)
- have a mental health condition that your doctor or the study team think might affect you taking part
Trial design
This study needs 1,500 men to take part. It is taking place at the Royal Marsden Hospital in London.
You see the study team and fill out a questionnaire about your medical history and family history of cancer. You will also answer questions about any prostate cancer screening tests you have had, for example a PSA blood test. Then you:
- have a blood test
- give 2 urine samples
- have a prostate examination
- have the distance between your anus and your testicles measured because researchers think there might be a link with prostate cancer
You are offered a biopsy (some tissue taken) of the prostate gland. You do not have to have this done if you don’t want to. You can still take part in the study.
Before having a biopsy the team ask if you would be willing to have an MRI scan. They may ask if you would have an ultrasound scan too. You have these on another day before your biopsy.
The scans help the doctor to see where it is best to do the biopsy. But they are for research purposes only. If you don’t want to have these scans you don’t have to. You can still take part in the study.
You have a transperineal biopsy.
The doctor puts a small ultrasound scan probe in your back passage. This is to guide the needle they use for the biopsy. They put a needle into the prostate through the area behind the testicles (perineum). You usually have a local anaesthetic for this and can go home the same day. If you have a general anaesthetic you might need to stay in hospital overnight.
After this biopsy it is important you drink a lot of fluids for the next 24 hours.
There is a small risk you might develop an infection after your biopsy. Your doctor might prescribe antibiotics to prevent this.
Your doctor will tell you whether you are having a TRUS or transperineal biopsy.
Results showing prostate cancer
When your results are back you will see the team again. If your results show that you have prostate cancer, a specialist will discuss your treatment options with you.
Results showing atypical small acinar proliferation (ASAP) or high grade prostatic intra epithelial (HG PIN)
ASAP and HG PIN are not cancer. But they could develop into cancer over time.
You see the doctor at 6 months for another biopsy and MRI scan. If this biopsy shows either ASAP or HG PIN you continue to have another biopsy and MRI scan every year.
After the biopsy
The team will also give you information about your genetic profile. If you have any gene changes that may be linked to prostate cancer, they will tell you about these. But as this profile is just a research test, the team will not yet fully understand what the results mean. So they will contact you yearly for the next 5 years. You get a questionnaire to check for any health changes. The team will also tell you about anything new they have discovered about the gene test results.
Hospital visits
You will see the study team 3 or 4 times in 6 months. Each visit will take up to an hour.
If you agree to have the MRI scan and also an ultrasound scan you need to make an extra hospital visit for this.
Side effects
The team might find prostate cancer even if you don't have any symptoms. If this happens a specialist will talk to you. They'll tell you how big (the stage) the cancer is, what this means for you and whether you need any treatment.
We have information about what to expect after having a transperineal biopsy.
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
Cancer Research UK
Biomedical Research Council (BRC)
Institute of Cancer Research (ICR)
Movember Foundation
National Institute for Health Research (NIHR)
Prof Eeles Research Fund
Ronald and Rita McAulay Fund
Other information
You can contact the PROFILE study team at prostate.research@rmh.nhs.uk
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
