Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

The STAMPEDE study is a big research project testing new and improved ways to treat prostate cancer that is either advanced or has a high chance of becoming advanced. This includes men who are starting hormone therapy for the first time. The study compares new treatment approaches, like adding extra medications or trying different types of hormone therapy, against the standard treatments currently used. The main goals are to help men live longer, or to live as long but with fewer side effects, improving their overall quality of life. Some results are already known, and new parts of the study are looking at metformin and a different hormone treatment called transdermal oestradiol.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Medical Research Council

Enrolment target

11,992

Start

08 Jul 2005

Estimated completion

01 Dec 2030

Prostate Cancer

What is this study about?

The STAMPEDE study is a large, ongoing research project looking for the best ways to treat prostate cancer, especially when it's advanced or has a high risk of spreading. This study focuses on men who are just starting a common treatment called hormone therapy (also known as ADT) for the first time. The doctors and researchers running STAMPEDE want to find treatments that can help men live longer and enjoy a better quality of life. They do this by comparing different treatment approaches against what is currently considered the standard care.

Over the years, STAMPEDE has tested various treatments, including common drugs like docetaxel and zoledronic acid, as well as newer medications like abiraterone and enzalutamide. Some of these tests have already provided important information that helps doctors treat prostate cancer today. The study is designed to keep learning, so new treatment ideas are regularly added to be tested.

Currently, new participants might be offered to test two specific treatments: metformin and transdermal oestradiol. Metformin is typically used for diabetes, but researchers are looking at whether it might also help treat prostate cancer and reduce side effects of other treatments. Transdermal oestradiol is a different way to deliver hormone therapy that might have fewer side effects than the usual methods. By comparing these new approaches with standard care, STAMPEDE aims to improve future treatment for prostate cancer patients.

Key takeaways

STAMPEDE is a large UK study looking for better prostate cancer treatments.
It aims to improve survival and quality of life for men with advanced or high-risk prostate cancer.
The study tests new treatments against current standard care.
Current new treatments being tested include metformin and a different hormone therapy called transdermal oestradiol.
You might receive standard treatment or one of the new treatments through a random assignment.
Participation involves regular check-ups and taking study medications.

Who may be eligible?

This study is looking for men with prostate cancer who are about to start long-term hormone therapy for the first time. You might be eligible if your cancer is advanced, meaning it has spread to other parts of your body, or if it's considered to be at a high risk of spreading, even if it hasn't yet.

You could also be eligible if you've already had treatments like surgery or radiotherapy, but your cancer shows signs of returning. Generally, you need to be well enough for all the study treatments, with good blood and kidney function. You'll also need to be willing to follow the study's plan and attend all appointments.

There are some reasons why you might not be able to join. For example, if you've already had certain types of prostate cancer treatment before, or if you've been on hormone therapy for a long time. The study also has specific rules about other medical conditions or medications you might be taking.

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.

Do I have prostate cancer that is advanced or high-risk?
Am I about to start hormone therapy for the first time?
Am I generally well enough to participate in a study?
Do I have good blood and kidney test results?
Have I had certain prior prostate cancer treatments that might exclude me?
Am I willing to have regular hospital visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the STAMPEDE study, you would first have a full discussion with your doctor and sign a consent form. Once you've joined, a computer program will randomly assign you to one of the study groups. This means you might receive the current standard treatment, or one of the new treatments being tested, or a combination.

The study involves regular check-ups with your medical team. These appointments will include physical examinations, blood tests, and possibly scans to monitor your health and how your cancer is responding to treatment. You will be taking the study medication as prescribed, and your doctors will be monitoring you to ensure your safety. The total duration of your participation will depend on the treatment arm you are in and how your cancer responds, but follow-up is long-term to understand the full effects of the treatments.

Potential risks and benefits

Taking part in this study could offer carefully monitored treatment and contribute to important medical research. You might receive a new treatment that could be more effective or have fewer side effects than current standard care. However, like all medical treatments, there's always a possibility of side effects or that the new treatment might not work as well for you. Your health will be closely watched by the study team, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (120)

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

Lausanne Centre Hospitalier Universitaire
Verified postcode
Lausanne, Switzerland
Winterthur Hospital
Verified postcode
Winterthur, Switzerland
Kantonsspital Graubuenden
Verified postcode
Chur, Switzerland
Hirslanden Klinik Aarau
Verified postcode
Aarau, Switzerland
Universitaetsspital-Basel
Verified postcode
Basel, Switzerland
Inselspital Bern
Verified postcode
Bern, Switzerland
Liestal Hospital
Verified postcode
Liestal, Switzerland
Kantonsspital - St. Gallen
Verified postcode
Sankt Gallen, Switzerland
UniversitaetsSpital Zuerich
Verified postcode
Zurich, Switzerland
City Hospital Triemli
Verified postcode
Zurich, Switzerland
Berkshire Cancer Centre at Royal Berkshire Hospital
Verified postcode
Reading, United Kingdom
Royal Bolton Hospital
Verified postcode
Farnworth, United Kingdom

Common questions

What kind of prostate cancer is this study for?

This study is for prostate cancer that is advanced (has spread) or is considered high-risk and has not yet been treated with long-term hormone therapy.

What is 'standard treatment' in this study?

Standard treatment usually involves hormone therapy, sometimes combined with radiotherapy to the prostate or a chemotherapy drug called docetaxel.

Will I get a new drug if I join?

You might. You'll be randomly assigned to receive either the standard treatment or one of the new treatments being tested, or a combination.

What are metformin and transdermal oestradiol?

Metformin is a diabetes drug being tested for its potential anti-cancer effects. Transdermal oestradiol is a different type of hormone therapy that might have fewer side effects.

How long does the study last?

Your involvement in the study will continue as long as your treatment is ongoing and for a follow-up period, to ensure we fully understand the long-term effects. This can be many years.