Active not recruitingOBSERVATIONAL

Exploiting Risk-Based Risk Stratification in Early Prostate Cancer to Discriminate Progressors From Non-Progressors

This study focuses on men with an early, less aggressive form of prostate cancer, called intermediate-risk, who are being carefully watched (this is known as 'active surveillance'). The main goal is to understand why some of these cancers become more serious over time, while others don't. Researchers will collect MRI scans and different biological samples, like blood and urine, from participating men at the start of the study and a year later. By comparing these samples, they hope to identify key differences at a very detailed level (molecular, genetic) between cancers that get worse and those that stay stable. This information could help doctors in the future to better predict how a man's prostate cancer will behave, leading to more personalised care and treatment plans.

At a glance

Status

Active not recruiting

Sponsor

University College, London

Enrolment target

Start

01 Jul 2020

Estimated completion

01 Dec 2028

Prostate Cancer

What is this study about?

This study is designed to help us understand more about early prostate cancer, specifically for men who have what's called 'intermediate-risk' prostate cancer. This means the cancer is not very aggressive, and doctors are keeping a close eye on it rather than treating it immediately – a process known as 'active surveillance'. The problem is, sometimes these cancers stay stable, but other times they can become more serious and need treatment. Currently, it's hard to tell which will happen.

The researchers in this study want to find out why some intermediate-risk prostate cancers progress (get worse) and others don't. They plan to do this by carefully looking at men's MRI scans and various samples (like blood, urine, and tiny pieces of prostate tissue from biopsies) at the beginning of the study and again one year later. By comparing these over time, they hope to spot subtle differences in the cancer's make-up that could act as warning signs.

The main aim is to discover 'markers' – these are like clues – at a very tiny level within the cancer cells that can predict if a cancer is likely to grow or stay put. If successful, this research could lead to better tests in the future. These tests could help doctors decide which men need treatment sooner and which can safely continue with active surveillance, avoiding unnecessary treatments and their side effects.

Key takeaways

This study aims to understand why some early prostate cancers become more serious while others don't.
It involves men with 'intermediate-risk' prostate cancer who are under 'active surveillance'.
Participation includes MRI scans, prostate biopsies, and providing blood and urine samples at specific times.
The study itself does not provide new treatments; it's focused on gathering information.
The research could lead to better tools for predicting cancer behaviour and more personalised care in the future.
Your involvement would last around 12 months following initial assessments.

Who may be eligible?

To be considered for this study, you would need to be a man aged 18 or older who has been told you have prostate cancer within the last four months. Your doctors should classify your cancer as 'intermediate risk,' meaning it's not the most aggressive type and is being managed with 'active surveillance' (regular monitoring).

There are also some specific medical details about your prostate cancer and MRI scan that your doctor would need to confirm. For example, your PSA level should be within a certain range, and your MRI scan results should match what the biopsy showed. The cancer should also meet specific size criteria from the biopsy.

You wouldn't be able to join if you have certain medical conditions that prevent you from having an MRI scan, such as a pacemaker or some metal implants. Also, if you've had certain treatments for prostate cancer before, or have had other prostate surgery, you wouldn't be eligible. It's also important that you can understand the study information and give your permission to take part.

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 18 or over?
Have you been diagnosed with intermediate-risk prostate cancer within the last 4 months?
Are you currently on 'active surveillance' for your prostate cancer?
Do you have a PSA level of 15 ng/ml or less?
Are you able to have an MRI scan (e.g., no pacemaker or certain metal implants)?
Have you *not* had previous treatment for prostate cancer or other major prostate surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey would typically start with an MRI scan, followed by a guided biopsy. During this biopsy visit, you would provide blood and urine samples, and the research team would collect extra tissue samples beyond what's needed for your regular care. If you've already participated in the ReIMAGINE study, some of these initial steps might not be necessary, as your existing data could be used.

Throughout the study, you'll have regular PSA blood tests every three months, just as you would under standard active surveillance. If your PSA suggests your cancer might be progressing, you would have another MRI and biopsy sooner than planned. Otherwise, you would return after 12 months for a repeat MRI scan and biopsy, along with further blood and urine samples. After this 12-month visit, your participation in the study would be complete.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could significantly help men with prostate cancer in the future by improving our understanding and leading to better ways to manage the disease. As with medical procedures, there are some potential risks, mainly related to the MRI scans and biopsies, such as discomfort or a small risk of infection from the biopsy. You would have extra blood tests, and the biopsies would involve a few more tissue samples being taken. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

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

University College Hospital
Verified postcode
London, United Kingdom

Common questions

What is 'active surveillance'?

Active surveillance means your doctors are closely watching your prostate cancer with regular tests, like PSA blood tests and MRI scans, instead of treating it straight away. This is often an option for slower-growing cancers.

What is an 'intermediate-risk prostate cancer'?

This refers to a prostate cancer that is not considered very aggressive, but it also isn't the lowest risk. It usually means the cancer cells look a bit more abnormal under the microscope than very low-risk types.

Will I receive any new treatment in this study?

No, this is an 'observational' study. This means researchers will be gathering information and samples to learn more. You won't receive any new medications or treatments as part of the study itself.

How long will I be involved in the study?

After your initial visits, you'll have your regular PSA tests, and then a repeat MRI and biopsy after 12 months. Your participation in the study itself will finish after that 12-month visit.

What are the extra samples for?

The extra blood, urine, and tissue samples are for research purposes. They will help scientists look for tiny differences in your cancer at a very detailed level, which could help predict if it will grow or not.