RecruitingOBSERVATIONAL

Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations

The GENPROS study is investigating how prostate cancer affects men who have rare changes in certain genes, such as BRCA1, BRCA2, HOXB13, and those linked to Lynch Syndrome. These gene changes can increase the risk of prostate cancer. Researchers will look at how these men respond to their prostate cancer treatment compared to men whose genes don't have these specific changes. They will review past and current medical information and may test blood or saliva samples to learn more. The goal is to better understand how these gene changes influence prostate cancer outcomes. This information will help doctors in the future to make better decisions about treatment for men with prostate cancer and these gene changes.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

4,260

Start

01 Sep 2014

Estimated completion

01 Dec 2035

Prostate Cancer

What is this study about?

Prostate cancer is a common cancer in men, especially as they get older. While many men do well with treatment, some types of prostate cancer can be more serious. We know that genetics, meaning traits passed down in families, play a role in who gets prostate cancer. Scientists have found many tiny genetic differences that can slightly increase a man's risk.

However, some much rarer gene changes, like those in the BRCA1, BRCA2, HOXB13 genes, or those linked to Lynch Syndrome, can significantly increase a man's risk of developing prostate cancer. In addition to a higher risk, some of these gene changes, particularly BRCA1 and BRCA2, might mean a man's prostate cancer could be more aggressive or harder to treat.

This study, called GENPROS, wants to understand this better. We're looking at men who have these specific rare gene changes and have been diagnosed with prostate cancer. We will compare their experiences and how well their treatments worked to men with prostate cancer who don't have these gene changes. This research is really important because it could help doctors understand which men might need closer monitoring or different treatment approaches, ultimately leading to better care for those with prostate cancer and these particular gene changes.

Key takeaways

Study looks at how rare gene changes affect prostate cancer.
Compares outcomes in men with and without these gene changes.
Information gathered from medical records and optionally blood/saliva.
Aims to find better ways to treat prostate cancer for specific groups.
Your treatment won't change by joining this study.
Your participation helps future patients with prostate cancer.

Who may be eligible?

This study is looking for men aged 18 and older who have been diagnosed with prostate cancer. You might be able to take part if you already know that you carry one of these specific rare gene changes (like BRCA1, BRCA2, HOXB13, or those related to Lynch Syndrome).

Alternatively, you could also be eligible if you have prostate cancer and it's known that you do NOT carry one of these specific gene changes. We need both groups for comparison.

You would not be able to join if you are under 18, cannot understand what is involved and give your permission, if there isn't enough information available about your medical history, or if your genetic status for these specific genes is unknown.

Quick self-check

Are you a man aged 18 or older?
Have you been diagnosed with prostate cancer?
Do you know if you carry one of the specific gene changes (like BRCA1, BRCA2, HOXB13, Lynch Syndrome) OR if you do NOT?
Are you able to provide your consent to take part?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the main thing you'll be doing is sharing your medical information. Researchers will look at your past and current medical records related to your prostate cancer diagnosis and treatment. This includes information about the type of treatment you received and how you responded to it. They may also collect existing tissue samples from your tumour if available.

Optionally, if you agree, you might be asked to provide a blood or saliva sample. This sample would be used for genetic testing to see if any other inherited factors might be linked to prostate cancer outcomes. There are no study medications involved, and no extra hospital visits beyond your usual medical care. The researchers will simply be gathering information over time.

Potential risks and benefits

A potential benefit of joining this study is that you would be contributing to vital research that aims to improve our understanding of prostate cancer, especially for men with rare gene changes. This could lead to better treatments and management strategies in the future, helping countless others. The main risk involved would be the time and effort required to provide consent and potentially a sample, as well as the sharing of your personal medical data, which would be handled with strict confidentiality. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your usual medical care.

Locations (1)

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

Common questions

What kind of gene changes are you looking at?

We're focusing on rare inherited gene changes in BRCA1, BRCA2, HOXB13, and genes linked to Lynch Syndrome, as these can increase prostate cancer risk.

Will this study change my current prostate cancer treatment?

No, this study is about observing and learning. It won't change your current treatment, but the findings could help others in the future.

Do I need to give blood or saliva?

Providing a blood or saliva sample is optional. You can still participate in the study by sharing your medical information without giving a sample.

Who will see my personal information?

Your personal medical information will be kept strictly confidential and anonymous whenever possible. Only authorised study staff will have access to it.

How long will I be part of the study?

The study involves looking at your medical information over time, both past and future. You won't have regular study appointments; they'll just gather data.

How to find out more

Elizabeth C Page, MSc

elizabeth.page@icr.ac.uk 44 208 722 4483 Official trial record

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