A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
STAMPEDE2 is a research study for men with prostate cancer that has spread to other parts of the body and still responds to hormone treatment. It's comparing two new ways of treating this cancer against the standard care currently given. The aim is to see if these new treatments can help slow the cancer's spread and improve how long people live. Thousands of men across the UK are expected to take part. All participants will get the best standard care, with some also randomly receiving one of the new treatments. This study is run by University College London, and open to men of all backgrounds aged 18 and over.
At a glance
What is this study about?
STAMPEDE2 is a research study, also called a clinical trial, that aims to find better ways to treat prostate cancer that has spread to other parts of the body but still responds to hormone therapy. This type of cancer is called 'metastatic hormone-sensitive prostate cancer'. Currently, there are standard treatments for this condition. This study is comparing two new treatments against the standard care to see if they can offer improved results over what's currently available.
The study is divided into different 'comparisons'. In each comparison, some participants will receive the standard care, while others will receive standard care plus one of the new research treatments. These treatments include a special type of targeted radiotherapy called SABR, which delivers focused radiation to areas where the cancer has spread, and a radioactive medicine called PSMA-Lutetium that aims to specifically target and treat prostate cancer cells. By comparing these, doctors hope to learn if these new approaches can help slow the cancer's growth and spread, and ultimately help people live longer and feel better.
Taking part in STAMPEDE2 means contributing to medical knowledge that could benefit many people with prostate cancer in the future. The trial is being run by experts at University College London and involves many hospitals across the UK, making it widely accessible. Participants will be carefully monitored with scans and tests, and doctors will be on the lookout for any side effects from the treatments. You can always stop taking part if you have serious side effects or no longer wish to continue.
Key takeaways
- Tests new treatments for prostate cancer that has spread and responds to hormones.
- Compares new options against standard care to find better treatments.
- Participants are randomly assigned to a treatment group.
- Includes targeted radiation (SABR) and a radioactive drug (PSMA-Lutetium).
- Requires regular check-ups, scans, and tests.
- Open to men aged 18+ with metastatic hormone-sensitive prostate cancer.
Who may be eligible?
This study is particularly for men who are at least 18 years old and have prostate cancer that has spread to other parts of their body, such as bones or other organs. The cancer must still be responding to hormone treatment, or if you've had previous hormone treatment, it needs to have stopped at least two years ago and you haven't had too much hormone treatment in total.
To join, doctors need to confirm your prostate cancer diagnosis, usually through a biopsy (tissue sample) or strong clinical suspicion. Scans like CT, MRI, or PET will have shown where the cancer has spread. Your overall health and ability to go about your daily activities should be generally good (what doctors call a WHO Performance Status of 0-2), or if you're a bit less active (Status 3), it should be mainly due to the cancer spread and expected to improve once you start hormone treatment.
It's also important that you have either started long-term hormone therapy or are planning to start it for at least two years. The research team will review all your medical information to make sure this study is the right fit for you.
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 18 years old or older?
- Has your prostate cancer spread, for example to bones or other organs?
- Does your cancer still respond to hormone treatment?
- Are you able to go about your daily activities reasonably well (WHO Performance Status 0-2)?
- Are you currently on or planning to start long-term hormone therapy?
- Do you have a confirmed diagnosis of prostate cancer?
What does participation involve?
If you decide to take part in STAMPEDE2, you'll first be registered for the study. Then, a computer system will randomly decide whether you receive the standard care or the standard care plus one of the new research treatments (SABR or PSMA-Lutetium). There's a 50% chance of getting one of the research treatments. Neither you nor your doctor can choose which treatment you receive; this helps ensure the study results are fair and unbiased.
Throughout the study, you'll have regular hospital visits for scans, blood tests, and other checks to monitor your cancer and how you're responding to treatment. The doctors will also carefully check for any side effects from the medicines. The specific number of visits and tests will depend on which comparison group you are in and will be explained in detail by the study team. Treatment will stop if the side effects become too severe, or if you simply decide you no longer wish to continue with the study.
The total duration of your participation in the treatment part of the study will vary, but even after treatment, you will be followed up with scans and tests. Your commitment to these follow-up appointments is important to gather complete information about the long-term effects of the treatments. You are free to withdraw from the trial at any time, for any reason.
Potential risks and benefits
Locations (18)
- Mount Vernon HospitalVerified postcodeBarnsley, United Kingdom· Recruiting
- AddenbrookesVerified postcodeCambridge, United Kingdom· Recruiting
- Royal Devon University Hospital TrustVerified postcodeExeter, United Kingdom· Recruiting
- Royal Devon & Exeter HospitalVerified postcodeExeter, United Kingdom· Recruiting
- The Princess Alexandra HospitalVerified postcodeHarlow, United Kingdom· Recruiting
- University College London Hospitals NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
- The Royal Marsden HospitalVerified postcodeLondon, United Kingdom· Recruiting
- Barts Health NHS TrustVerified postcodeLondon, United Kingdom· Recruiting
- North Middlesex HospitalVerified postcodeLondon, United Kingdom· Recruiting
- Royal Free HospitalVerified postcodeLondon, United Kingdom· Recruiting
- The James Cook University HospitalVerified postcodeMiddlesbrough, United Kingdom· Recruiting
- Churchill HospitalVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What does 'metastatic hormone-sensitive' mean?
It means the prostate cancer has spread to other parts of your body, but it still responds to hormone treatments that lower testosterone levels.
Will I definitely get one of the new treatments?
Because it's a 'randomised' study, you have a 50% chance of getting one of the new treatments plus standard care, or just standard care alone. A computer decides this fairly.
What kind of new treatments are being tested?
One is a targeted radiation treatment (SABR) for areas where cancer has spread, and the other is a special radioactive medicine (PSMA-Lutetium) that targets prostate cancer cells.
Who is running this study?
The study, called STAMPEDE2, is being run by University College London, and many hospitals across the UK are involved.
What if I change my mind about taking part?
You are free to leave the study at any time, for any reason, without it affecting your future medical care.
How to find out more
Pamela Niem
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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