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The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer

The IMPACT study is looking into how certain inherited gene changes affect a man's risk of getting prostate cancer. These gene changes are in genes called BRCA1, BRCA2, or Mismatch Repair genes. Some men involved in the study will have these gene changes, and others won't. Researchers will offer annual PSA blood tests to men with these changes to see how often prostate cancer develops in this group. They also want to understand if prostate cancer in these men behaves differently. The study aims to gather more information on whether regular screening for prostate cancer is helpful for men with these specific gene changes. The study needs to recruit men from all over the world to get enough participants.

At a glance

Status
Active not recruiting
Sponsor
Institute of Cancer Research, United Kingdom
Enrolment target
3,500
Start
01 Mar 2005
Estimated completion
01 Mar 2030

What is this study about?

The IMPACT study is an important international research project looking into the link between inherited gene changes and prostate cancer. Some men are born with changes in genes like BRCA1, BRCA2, or Mismatch Repair genes. These genes are usually known for increasing the risk of other cancers, but we are learning that they might also increase a man's risk of prostate cancer. Researchers want to understand this connection better, especially if prostate cancer in men with these gene changes might be more serious.

For this study, researchers will invite men with these specific gene changes to have regular PSA blood tests. PSA is a protein made by the prostate, and higher levels can sometimes suggest prostate problems, including cancer. By offering these tests annually, the study aims to find out how often prostate cancer develops in these men and if there are new ways to spot it early. They will also look at how genes and hormones might be involved in prostate cancer development in this group.

To get reliable results, the study needs a large number of participants. They are aiming for 850 men with these inherited gene changes and 850 men without them (who are of a similar age). The results could help doctors decide if special prostate cancer checks are needed for men with these specific inherited gene changes in the future.

Key takeaways

  • The IMPACT study is looking at inherited gene changes and prostate cancer risk.
  • It involves men with specific gene changes (like BRCA1/2) and men without them.
  • Participants will have regular PSA blood tests.
  • The goal is to see if gene changes increase prostate cancer risk and if screening helps.
  • It could help doctors decide future screening guidelines for men with these gene changes.

Who may be eligible?

To join the IMPACT study, you must be a man between 40 and 69 years old.

You can take part if you have a known inherited change in your BRCA1, BRCA2, or Mismatch Repair genes. You can also join if you don't have these inherited changes but are a similar age to those who do, as you would be part of the 'comparison group'.

It's important that you haven't been diagnosed with prostate cancer before and haven't had a prostate biopsy because of a high PSA level. Also, you should be generally well and able to follow the study schedule without difficulty.

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.

  1. Are you a man?
  2. Are you between 40 and 69 years old?
  3. Do you have a known inherited BRCA1, BRCA2, or Mismatch Repair gene change, or are you closely related to someone who does?
  4. Have you never been diagnosed with prostate cancer?
  5. Have you never had a prostate biopsy because of a high PSA test result?
Answer every question to see your result.

What does participation involve?

If you decide to join the IMPACT study, you will have annual check-ups. These check-ups will usually involve a simple blood test to measure your PSA levels. Researchers will also look for other early signs of prostate cancer in your blood. You won't be given any new medication as part of this study. The study aims to follow participants for several years, with annual visits, to gather enough information over time. The team will explain the full schedule of visits and what each involves in detail before you agree to take part.

Potential risks and benefits

A potential benefit of joining this study is closer monitoring for prostate cancer, which might lead to earlier detection if cancer develops. Your participation will also significantly help researchers understand how inherited gene changes affect prostate cancer risk, potentially improving care for future generations. As with any medical test, PSA screening can sometimes lead to anxiety or false alarms, and a biopsy (if suggested by high PSA) has its own small risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Cancer Genetics Unit, Royal Marsden Hospital
    Verified postcode
    Sutton, United Kingdom

Common questions

What is a 'gene change'?

A gene change, or mutation, is a small alteration in the instructions within our cells that can sometimes be passed down in families and might affect how our bodies work.

What is a PSA test?

A PSA test is a simple blood test that measures the amount of a protein called Prostate Specific Antigen. High levels can sometimes indicate a prostate problem.

Why are there two groups of men in the study?

Having two groups – men with the gene changes and men without – helps researchers compare results and confirm if the gene changes are truly linked to prostate cancer risk.

Does this study involve new treatments?

No, this study is about understanding prostate cancer risk and screening. It does not involve testing new medications or treatments.

How long will I be in the study?

The study involves annual check-ups over several years, but the exact duration for each participant will be explained by the study team.

How to find out more

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

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