Active not recruitingOBSERVATIONAL

Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer

This research study is investigating a new type of blood test to help doctors find the best treatments for men with prostate cancer that has spread. Instead of testing new medicines, the study focuses on 'plasma tumour DNA' (ptDNA), which cancer cells release and can be found in blood. By taking extra blood samples during standard treatment, researchers will look at ptDNA, along with other markers, to see if it can predict how well different treatments will work. This could help doctors in the future choose the most effective standard care for each patient. The study is also hoping to spot new ideas for developing future prostate cancer drugs.

At a glance

Status

Active not recruiting

Sponsor

University College, London

Enrolment target

192

Start

20 Sep 2019

Estimated completion

31 Oct 2030

Metastatic Prostate Cancer

What is this study about?

Prostate cancer is the most common cancer in men in the UK, affecting around 1 in 8 men during their lives. For many men, prostate cancer stays in one place, but for some, it can spread to other parts of the body. This is called metastatic prostate cancer. When cancer spreads, it can be more serious, and finding the right treatment is very important.

Currently, doctors use a few different treatments for advanced prostate cancer, often including chemotherapy or other hormone-blocking drugs. However, it can be hard to know early on if a treatment is truly working for an individual patient. This study, called PARADIGM, aims to change that. It's not about testing new drugs, but rather exploring if a smart new blood test can give doctors better information about which existing treatments might work best for a patient.

The study focuses on something called 'plasma tumour DNA' (ptDNA). This is tiny bits of genetic material that cancer cells release into the bloodstream. Researchers believe that by looking at this ptDNA, along with other signs in the blood, they might be able to tell if a treatment is effective much sooner. The ultimate goal is to help doctors pick the most suitable standard treatments for patients with advanced prostate cancer, leading to better care and outcomes in the future. It might also show new ways to develop even more effective drugs down the line.

Key takeaways

The study investigates a new blood test (ptDNA) for advanced prostate cancer.
It aims to help doctors choose the best existing treatments for patients.
No new drugs are being tested in this research.
Participation involves extra blood tests during standard treatment.
Results could lead to more personalised prostate cancer care in the future.
You will be followed for up to 10 years.

Who may be eligible?

This study is looking for men aged 18 or over who have prostate cancer that has spread to other parts of the body. This usually means the cancer has spread to at least five places in the bones, or to at least one organ.

You should also be generally well and able to carry out your daily activities without too much difficulty. You must be planning to start, or have recently started, certain standard treatments for prostate cancer, such as specific hormone therapies or chemotherapy.

Men who have already tried certain other treatments like radiotherapy to the main tumour, some hormone treatments, or surgery for their primary tumour might not be able to join. The study team will check all your medical details to see if you're a good fit.

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 aged 18 or older?
Do you have prostate cancer that has spread to other parts of your body?
Are you planning to start or have you recently started specific hormone-blocking drugs or chemotherapy for your prostate cancer?
Are you generally well and able to manage daily activities?
Are you willing to have extra blood tests during your treatment?
Have you *not* had certain previous treatments like radiotherapy to your main tumour or specific surgeries for your prostate cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new or experimental drugs. Instead, you'll have extra blood samples taken during your routine medical appointments. These samples will be analysed alongside your standard care to look at things like ptDNA, PSA levels, and other cells. You'll typically have blood taken before you start treatment, at different points during treatment, and if your cancer progresses. Some centres might also offer optional full-body MRI scans before and during treatment.

Your participation will involve regular follow-up for up to 10 years after you enrol, though the actual time you spend in regular visits will depend on your treatment plan and how your cancer responds. The researchers expect to recruit new participants for about 18 months, but your individual follow-up will continue after that.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to our understanding of advanced prostate cancer and helping future patients receive more personalised and effective treatments. It doesn't involve any new medicines, so you won't be exposed to unknown drug side effects. Any risks would primarily be from the extra blood tests, which are usually minor, like some bruising or discomfort. You also have the absolute right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (16)

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

Aberdeen Royal Infirmary
Verified postcode
Aberdeen, United Kingdom
Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom
Velindre University NHS Trust
Verified postcode
Cardiff, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Verified postcode
Doncaster, United Kingdom
Medway NHS Foundation Trust
Verified postcode
Gillingham, United Kingdom
The Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom
The Princess Alexandra Hospital NHS Trust
Verified postcode
London, United Kingdom
Barts Health NHS Trust, Royal London Hospital
Verified postcode
London, United Kingdom
Kingston Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom
Royal Free London NHS Foundation Trust
Verified postcode
London, United Kingdom
Guy's and St Thomas's NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is 'ptDNA'?

ptDNA stands for 'plasma tumour DNA.' It's tiny bits of genetic material from cancer cells that can be found in your blood.

Will I get a new drug in this study?

No, this study is not testing new drugs. It's looking at how a new type of blood test might help doctors choose the best *existing* treatments for you.

What does 'metastatic prostate cancer' mean?

It means the prostate cancer has spread from your prostate to other parts of your body, such as your bones or other organs.

How long will I be in the study if I join?

You will be followed up for a maximum of 10 years, though the intensive part of the study (like extra blood tests) will be during your active treatment.

Will this study change my current treatment plan?

No, the study design will not change your cancer treatment. It focuses on collecting information from blood samples taken alongside your standard care.