RecruitingOBSERVATIONAL

The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment

The PROFILE study aims to understand how genetics, family history, and ethnic background affect a man's risk of developing prostate cancer. This is important because prostate cancer is very common in men, and some groups, like those of Black African or Black African-Caribbean heritage, are known to have a higher risk. Researchers want to see if specific genetic changes can help identify men who are more likely to get prostate cancer. By comparing genetic information with the results of prostate scans and biopsies, the study hopes to discover if using genetic tests could improve how we screen for prostate cancer in the future. This could lead to earlier diagnosis and better treatment options for men at higher risk.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

1,600

Start

09 Mar 2015

Estimated completion

31 Dec 2026

Prostate Cancer Prostate Biopsy Genetic Counselling Genetic Markers

What is this study about?

The PROFILE study is investigating prostate cancer, which is the most common cancer among men in Western countries, including the UK. We know that conditions like prostate cancer can sometimes run in families, and scientists have found certain genetic differences that might increase a man's risk. Research also shows that men from specific ethnic backgrounds, such as those of Black African or Black African-Caribbean heritage, also face a higher risk.

This study is designed to look closely at men who already have a higher chance of developing prostate cancer, whether due to their family history, their ethnic background, or known genetic factors. The main goal is to see if specific changes in their DNA (their genetic material) are present. By understanding these genetic links, researchers hope to develop better ways to check for prostate cancer earlier, potentially using these genetic clues as a screening tool.

Participants in the study will undergo prostate cancer screening tests, including MRI scans and biopsies, and their genetic information will be collected. Scientists will then compare these results to see if there's a clear link between certain genetic profiles and the presence of prostate cancer. This research is crucial for understanding the role of genetics in prostate cancer screening and ultimately for identifying men who might benefit most from targeted screening programmes.

Key takeaways

Looks at how genetics, family history, and ethnicity affect prostate cancer risk.
Aims to find better ways to screen for prostate cancer using genetic information.
Involves men aged 40-69 with higher prostate cancer risk factors.
Includes MRI scans, PSA tests, and prostate biopsies for screening.
Your participation helps improve future prostate cancer detection methods.

Who may be eligible?

This study is looking for men between 40 and 69 years old. You might be able to take part if you have a family history of prostate cancer – for example, if a close male relative like a father or brother was diagnosed before age 70, or if multiple relatives had it.

Another group who might be eligible are men of Black African or Black African-Caribbean ancestry, meaning both your parents and all four grandparents are from these backgrounds. Finally, men of any ethnicity who are already known to have certain genetic changes that increase prostate cancer risk, or who have a high 'polygenic risk score' (a measure of overall genetic risk), could also be considered.

However, you won't be able to join if you've had cancer before that's expected to shorten your life significantly, or if you've already had prostate cancer. Also, if you've had a negative prostate biopsy within the last year, you won't be eligible. Some medical conditions, such as taking certain blood thinners, poorly controlled diabetes, or severe heart or breathing issues, might also prevent you from safely having a biopsy. A very high body mass index (BMI) or issues that make having an MRI scan impossible would also exclude you.

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 a man aged between 40 and 69?
Do you have a close family member (like father or brother) who had prostate cancer before age 70, or multiple family members with prostate cancer?
Are you of Black African or Black African-Caribbean ancestry (all parents and grandparents)?
Are you already aware that you have certain genetic changes that increase prostate cancer risk?
Have you NOT had prostate cancer before?
Are you generally well and fit enough for a biopsy and MRI scan?

Answer every question to see your result.

What does participation involve?

If you join the PROFILE study, you will have prostate cancer screening. This includes a special type of MRI scan of your prostate and, if necessary, a biopsy of your prostate gland to check for cancer cells. Your genetic material will be collected for analysis. This is an observational study, meaning researchers will monitor things that happen naturally rather than giving you a new treatment. The study aims to look at your risk factors and what happens with screening. The exact number of visits and the total duration isn't specified, but it will involve screening appointments and follow-ups related to the study's findings.

Potential risks and benefits

Taking part in this study could offer the benefit of early detection of prostate cancer if it's present, which could lead to earlier treatment. It also contributes to important research that may help many men in the future. Potential risks include those associated with MRI scans (such as claustrophobia) and prostate biopsies, which can have side effects like pain, bleeding, or infection. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Institute of Cancer Research and Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is genetic profiling?

Genetic profiling means looking at your DNA (genetic material) to find specific changes that might be linked to certain health conditions, like a higher risk of prostate cancer.

Why are some ethnic groups at higher risk of prostate cancer?

Research shows that men of Black African or Black African-Caribbean heritage have a higher risk of prostate cancer, though the exact reasons are still being studied, including potential genetic factors.

What is a prostate biopsy?

A prostate biopsy is a procedure where small tissue samples are taken from your prostate gland to check for cancer cells under a microscope.

Will I get my genetic test results back?

The study aims to correlate genetic profiles with screening outcomes, but it's best to ask the study team directly about receiving individual genetic results.

Is a PSA test part of this study?

Yes, Prostate Specific Antigen (PSA) testing is part of the targeted prostate screening mentioned for men enrolled in the study.

How to find out more

Elizabeth K Bancroft, PhD

elizabeth.bancroft@icr.ac.uk 44 207 808 2136 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.