All studies
RecruitingNAINTERVENTIONAL

Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)

The ATLAS study is for men with early-stage prostate cancer who are carefully watching their condition, a approach called 'active surveillance'. Current guidelines involve frequent blood tests and rectal exams, with MRI/biopsy usually after a year. This study wants to find out if using regular MRI scans from early on is a more effective way to detect if the cancer is growing or changing over five years. It aims to see if this approach is better than the current standard, potentially leading to fewer biopsies, clinic visits, and blood tests. This might improve how we monitor prostate cancer for those on active surveillance, ensuring they get the right treatment at the right time.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Imperial College London
Enrolment target
1,263
Start
24 May 2024
Estimated completion
01 Jun 2032

What is this study about?

When men are diagnosed with prostate cancer, especially if it's slow-growing or early stage, some choose 'active surveillance'. This means carefully watching the cancer rather than having immediate treatments like surgery or radiotherapy, which can have side effects. About 7,600 men in the UK choose this path each year. While active surveillance often works well, sometimes the cancer can grow or become more serious over time. Currently, checking for these changes involves regular blood tests for PSA (Prostate Specific Antigen) and physical exams, with MRI scans and biopsies usually happening after the first year if there are concerns.

The 'ATLAS' study, also known as Imperial Prostate 9, wants to improve how we monitor men on active surveillance. The main question is whether using regular MRI scans from the start is a better way to spot if the cancer is progressing compared to the current standard approach. MRI scans are good at seeing changes in the prostate without needing to take tissue samples (biopsies) as often, which can be uncomfortable and have side effects like infection. By using MRI more regularly, the hope is to find any significant cancer progression earlier and more accurately, potentially leading to fewer biopsies, blood tests, and hospital visits.

Ultimately, this study aims to find a safer, more accurate, and possibly more comfortable way for men on active surveillance to be monitored. This could help ensure that if a man's cancer does become more serious, it is detected promptly, allowing doctors and patients to make informed decisions about treatment at the right time, while also reducing the burden of frequent tests and appointments on the NHS.

Key takeaways

  • Focuses on improving monitoring for men on active surveillance for prostate cancer.
  • Compares regular MRI scans with current standard care over 5 years.
  • Aims to detect cancer changes more accurately and reduce need for biopsies.
  • Participation involves being assigned to one of two monitoring groups.
  • The study lasts for five years, with ongoing check-ups.

Who may be eligible?

This study is looking for men aged 18 or over who have been diagnosed with localised prostate cancer. This includes men who were born male or those who identify as female but still have a prostate and haven't had hormone treatment that lowers testosterone.

You should have had an MRI scan and a biopsy that helped diagnose your cancer. Importantly, you must have chosen 'active surveillance' as your way of managing your prostate cancer. This means you're currently monitoring your cancer rather than having active treatment like surgery or radiotherapy.

There are a few reasons why you might not be able to join. For example, if you've already been on active surveillance for more than nine months before you're considered for this study, or if you can't have an MRI scan due to a medical reason (like having certain metal implants or allergies to the dye sometimes used in MRI). Also, if you've had both hips replaced or can't have a specific type of biopsy, you would not be able to participate.

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 18 or older?
  2. Do you have a prostate and haven't had hormone therapy that lowers testosterone?
  3. Have you been diagnosed with localised prostate cancer?
  4. Are you currently on active surveillance for your prostate cancer?
  5. Are you able to have an MRI scan?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. Neither you nor your doctor will know which group you're in until it's decided. One group will have regular MRI scans as part of their monitoring. The other group will follow the current standard monitoring plan recommended by NICE (National Institute for Health and Care Excellence), which involves regular PSA blood tests and rectal exams, with an MRI and biopsy typically after a year.

The study will last for five years. Depending on which group you're in, you will have specific tests during this time. This might include MRI scans, PSA blood tests, rectal exams, and potentially biopsies if your doctor thinks it's necessary based on the results. The goal is to compare how well each approach detects cancer progression, so you'll be closely monitored throughout the study period.

Potential risks and benefits

Participating in this study might offer an improved way for your prostate cancer to be monitored, potentially leading to earlier detection of any spread and possibly fewer biopsies or clinic visits, depending on your assigned group. However, there are some potential risks. MRI scans, while generally safe, might involve discomfort for those who dislike enclosed spaces, and some patients might have reactions to the contrast dye used. Biopsies, if needed, carry risks like infection, bleeding, and pain. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Heatherwood Hospital
    Verified postcode
    Ascot, United Kingdom· Recruiting
  • Darent Valley Hospital
    Verified postcode
    Dartford, United Kingdom· Recruiting
  • Bradford Royal Infirmary
    Verified postcode
    Bradford, United Kingdom· Recruiting
  • St Peter's Hospital
    Verified postcode
    Chertsey, United Kingdom· Recruiting
  • Charing Cross Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Kings College London
    Verified postcode
    London, United Kingdom· Recruiting
  • West Middlesex Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Freeman Hospital
    Verified postcode
    Newcastle upon Tyne, United Kingdom· Recruiting
  • Glan Clywd Hospital
    Verified postcode
    Rhyl, United Kingdom· Recruiting
  • Northern Lincolnshire and Goole NHS Foundation Trust
    Verified postcode
    Scunthorpe, United Kingdom· Recruiting
  • Southampton University Hospital
    Verified postcode
    Southampton, United Kingdom· Recruiting
  • North Cumbria
    Verified postcode
    Whitehaven, United Kingdom· Recruiting

Common questions

What is 'active surveillance'?

Active surveillance means carefully watching your prostate cancer rather than treating it immediately, using regular tests to check for changes.

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, like your prostate.

Why is this study important?

It aims to find a better, more accurate way to monitor men on active surveillance, potentially reducing the need for invasive biopsies and frequent appointments.

Will I know if I'm getting MRI scans or standard care?

Yes, you and your doctor will know which group you are in, so you'll be informed about your monitoring plan.

How long will I be in the study?

The study aims to follow participants for five years to see the long-term effectiveness of each monitoring approach.

How to find out more

Hashim Ahmed

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

Interested in taking part?

Register your interest

Share your details and the research team for "Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.