Active not recruitingPHASE2INTERVENTIONAL

The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

The BARCODE 2 study is looking into men with advanced prostate cancer that has stopped responding to standard hormone treatments. We know that some men have small changes in their genes, particularly those involved in fixing damaged DNA, which might affect how their cancer responds to certain medicines. This study will check if having these gene changes means a specific chemotherapy drug, carboplatin, works better for them. The study has two parts: first, men will have a genetic test to see if they have these gene changes. If they do, and are suitable, they may then be offered carboplatin treatment. The aim is to understand if this treatment is more effective for men with these particular genetic changes, which could lead to more personalised treatments in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

305

Start

25 May 2017

Estimated completion

31 Dec 2028

Hormone Refractory Prostate Cancer

What is this study about?

Prostate cancer is very common among men in the UK. Doctors and scientists have found that some men with prostate cancer have changes in certain genes. These genes are important because they normally help repair damaged DNA in our bodies. Sometimes, if these DNA repair genes aren't working properly, it might be linked to how prostate cancer develops and how it responds to treatment. This study, called BARCODE 2, wants to investigate this connection.

The study is divided into two main parts. In the first part, we're inviting men with advanced prostate cancer who haven't had genetic testing before to have a special test. This test will look closely at their DNA to see if they have any of these specific changes in their DNA repair genes. If a significant gene change is found, they'll then be offered the chance to move on to the second part of the study.

In the second part, men who are known to have these specific genetic changes (either from the first part of the study or from previous tests) will be offered a chemotherapy treatment called carboplatin. The main goal is to see how well these men respond to carboplatin. This will help doctors understand if men with these particular gene changes respond better to this type of chemotherapy. Ultimately, this research aims to help doctors choose the best treatments for men with prostate cancer based on their individual genetic makeup.

Key takeaways

The study explores if genetic changes affect how advanced prostate cancer responds to carboplatin.
It involves men with prostate cancer that no longer responds to hormone therapy.
Participation might include genetic testing and potentially carboplatin treatment.
The goal is to find better, more personalised treatments for prostate cancer.
Key measures of success include changes in PSA levels and scan results.
You can withdraw from the study at any time without affecting your NHS care.

Who may be eligible?

This study is for men aged 18 or over who have advanced prostate cancer that is no longer responding to standard hormone treatments. You would typically have already received other treatments like docetaxel chemotherapy or certain hormone-blocking medicines (like abiraterone or enzalutamide).

If you haven't had a genetic test before, you might join the first part of the study to see if you have specific gene changes. If you already know you have these particular gene changes, or if they are found during the first part, you might then be suitable for the second part.

You also need to be generally well enough to take part, with healthy kidney function and certain blood test results. The study doctor will check all these details carefully to make sure it's safe for you to join.

Quick self-check

Are you 18 years old or older?
Do you have advanced prostate cancer that has stopped responding to hormone treatments?
Have you already had treatments like docetaxel (a chemotherapy) or certain hormone-blocking drugs?
Are you generally well enough for a clinical study (your doctor will check this)?
Are you male?
Can you understand the study information and give your consent?

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, you'll first be given detailed information to read and discuss. You'll have plenty of time to ask any questions. If you agree, you'll sign a consent form.

For men joining the first part: You will have a genetic screening test to look for specific gene changes. This will involve providing a sample, likely blood or tissue, for testing. If a significant gene change is found, and you meet other health requirements, you'll be offered the option to proceed to the second part of the study.

For men joining the second part (which would involve treatment with carboplatin): Before starting carboplatin treatment, doctors will carry out further checks to make sure the treatment is safe for you. This will involve regular clinic visits, blood tests, and scans to monitor your health and how well the treatment is working. You will receive carboplatin chemotherapy, and doctors will carefully watch for any side effects and track your progress through blood tests (like PSA levels) and imaging scans. The total duration of your participation will depend on your response to treatment and the study schedule, but regular follow-up will be involved.

Potential risks and benefits

Taking part in a study like this may offer potential benefits, such as receiving specific genetic information or a new treatment approach for your condition. However, there are also potential risks associated with any medical procedure or treatment. You might experience side effects from the genetic testing or the carboplatin chemotherapy, which your medical team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

Common questions

What is 'hormone refractory prostate cancer'?

This is prostate cancer that has stopped responding to hormone treatments, which are usually the first line of defence.

What are 'DNA repair genes'?

These are special genes in your body that help to fix damage to your DNA. If they don't work properly, it can sometimes be linked to cancer.

What is carboplatin?

Carboplatin is a chemotherapy drug used to treat certain types of cancer by killing fast-growing cells.

Will I automatically get carboplatin if I join the study?

No, not necessarily. First, you'll have genetic testing. If certain gene changes are found and you meet all other health requirements, you'll then be offered the option to receive carboplatin as part of the study.

Will my information be kept private?

Yes, all your personal and medical information will be kept confidential and handled according to strict privacy rules.