RecruitingOBSERVATIONAL

Microbiome Molecular Charaterisation

This study, called Microbiome Molecular Characterisation, is investigating how the tiny living organisms (the 'microbiome') in our gut might influence prostate cancer. Doctors know that current treatments for advanced prostate cancer don't always work long-term, and they want to understand why. They believe that the gut microbiome could play a big role in how the disease progresses and how well different treatments work, or if they cause side effects. By studying samples from patients, including tissue and gut samples, researchers hope to discover new ways to predict treatment success, reduce unwanted side effects, and ultimately improve therapies for prostate cancer patients. This study is observational, meaning patients will be carefully monitored.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

1,000

Start

23 Oct 2023

Estimated completion

01 Oct 2038

Prostate Cancer

What is this study about?

Prostate cancer is a common illness in men in the UK. While current treatments are often very effective at first, sometimes the cancer becomes resistant over time. Researchers are constantly looking for better ways to understand and treat prostate cancer. This study is exploring a fascinating new area: the human microbiome. This refers to the billions of tiny germs, like bacteria, that live inside and on our bodies, especially in our guts. We're learning that these tiny organisms can have a big impact on our health, including how our bodies react to illnesses like cancer and to various medicines.

For a long time, doctors have noticed that laboratory models don't always perfectly predict how prostate cancer will behave in real patients. This study aims to bridge that gap by looking directly at samples from men with prostate cancer. The main idea is to see if the specific mix of germs in a person's gut is linked to how their prostate cancer progresses, how well their treatments work, or what side effects they might experience. Researchers believe that if they understand these connections, they might be able to develop new strategies to make treatments more effective and safer.

This research is a detailed look at the biology of prostate cancer and its relationship with the microbiome. By carefully examining tissue samples and gut bacteria, the scientists hope to gain valuable insights. The knowledge they gain could lead to new tools for predicting the best treatments for individual patients, preventing unpleasant side effects, and even finding new targets for future medicines to fight prostate cancer. It's a key step towards more personalised and effective care.

Key takeaways

This study investigates how gut germs (microbiome) affect prostate cancer.
It aims to understand why some treatments work better or cause fewer side effects.
Participation involves providing tissue and other samples, like from the gut.
No new treatments are given; it's an observational study.
The goal is to find new ways to improve future prostate cancer care.

Who may be eligible?

To be considered for this study, you need to be a man aged 18 or older. You should be generally well enough to go about your daily activities, even if you have some limitations, as long as your doctor agrees you are fit enough. You must either be undergoing tests for prostate cancer, have a confirmed diagnosis, or be taking part in another clinical trial for prostate cancer, and having further investigations related to this.

An important part of this study is being able to provide a fresh sample of your tumour tissue. This means your doctor must believe it's safe for you to have a biopsy (a procedure to take a small piece of tissue) and that you are medically fit enough for this procedure. You also need to be willing to follow all the study instructions and provide written permission to participate. We'll also need a recent record of your PSA levels.

There are a few reasons why you might not be able to join. For example, if you have blood disorders that would make a biopsy unsafe, or if you have any mental health or social challenges that would make it difficult to reliably take part in the study. Your doctor will also consider any other health conditions that might put you at risk or affect the study results.

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 older?
Are you able to have a fresh tumour biopsy safely?
Do you have a diagnosis of prostate cancer or are you being investigated for it?
Are you willing to provide samples and follow study instructions?
Do you have a recent PSA level recorded?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to provide a fresh sample of your prostate cancer tissue. This will usually involve a biopsy, which is a common procedure where a small piece of tissue is taken for examination. This sample will then be sent to special laboratories for detailed analysis. You will also be asked to provide other samples, such as stool samples, so researchers can look at your gut microbiome.

This is an 'observational' study, which means you won't be given any new treatments or medicines from the study team. Instead, researchers will collect samples and information while you receive your usual care for prostate cancer. There won't be specific study visits beyond what you would normally have for your ongoing care, but there will be specific procedures for collecting the tissue sample and other samples required for the research.

The overall duration of your participation will depend on your ongoing treatment plan and how long samples are needed. The study team will explain the full timeline and requirements to you in detail before you agree to join.

Potential risks and benefits

Potential benefits from this study won't directly improve your current health, as it's an observational study designed to gain knowledge. However, the information gathered could greatly benefit future prostate cancer patients by leading to better understanding of the disease, more effective treatments, and ways to reduce side effects. The main risk involves the biopsy procedure itself, which carries standard risks like pain, bruising, bleeding, or infection. Your doctor will discuss these fully with you. You have the right to withdraw from the study at any time, for any reason, 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.

Institute of Cancer Research/Royal Marsden NHS FT
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is the 'microbiome'?

The microbiome is the collection of all the tiny living organisms, like bacteria, fungi, and viruses, that live in and on our bodies, especially in our gut. They play an important role in our health.

Will I receive new treatment if I join this study?

No, this is an 'observational' study. You will continue to receive your standard medical care, and the study will collect samples and information from you.

What kind of samples will be taken?

You will be asked to provide a fresh tumour tissue sample, usually through a biopsy, and potentially other samples like stool samples to study your gut microbiome.

Will taking part in this study change my regular prostate cancer treatment?

No, participating in this study will not change the treatment plan your doctor has recommended for your prostate cancer.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Omobola Fadahunsi

bola.fadahunsi@icr.ac.uk 0203 437 3500 Official trial record

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