RecruitingOBSERVATIONAL

Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy

This research study is for men with prostate cancer who are receiving a specific type of radiation treatment called brachytherapy. Brachytherapy involves placing tiny radioactive 'seeds' directly into the prostate gland. The study aims to understand how the body's natural defence system, called the immune system, responds to this treatment. Researchers will be looking at cells from the blood and, in some cases, tissue from the prostate itself, before, during, and after brachytherapy. The goal is to discover how these immune markers change and whether they play a role in how well the treatment works against prostate cancer, including cases where the cancer has come back.

At a glance

Status

Recruiting

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

200

Start

01 Dec 2025

Estimated completion

31 Jul 2028

Prostate Cancer (Diagnosis)Prostate Cancer Patients Who Have Brachytherapy Seed Implant Prostate Cancer Patients Treated by Radiotherapy Prostate Cancer Recurrent

What is this study about?

This study is focused on men with prostate cancer who are undergoing a special type of radiation treatment called brachytherapy. Think of brachytherapy as a very targeted way to deliver radiation directly to the prostate gland using tiny radioactive 'seeds'. The main idea behind this research is to explore how your body's immune system – which is your natural defence against illnesses – reacts to this treatment. We know that the immune system is crucial for fighting diseases like cancer, and researchers want to see if brachytherapy can also help activate or improve the immune response against prostate cancer.

The researchers will be collecting blood samples at different times: before you start brachytherapy, during the treatment period, and after it's completed. From these blood samples, they will carefully examine the immune cells to see how they change over time. In some cases, if you have a biopsy (a procedure to take a small tissue sample) as part of your brachytherapy, those tissue samples will also be looked at to understand the immune system's activity within the prostate itself.

By doing this, the scientists hope to gain a better understanding of how brachytherapy affects your immune system. This could lead to a future where we can predict who will respond best to treatment, or even find new ways to combine brachytherapy with other treatments to make them even more effective at beating prostate cancer.

Key takeaways

Study looks at immune system changes during prostate cancer brachytherapy.
It aims to understand how the body's natural defences react to treatment.
Blood and tissue samples will be collected at different times.
Participation will not change your planned cancer treatment.
The findings could help improve future prostate cancer care.

Who may be eligible?

This study is looking for men aged 18 and over who have prostate cancer.

There are two main groups for this study. The first group is for men who are having brachytherapy for the first time as their main treatment for prostate cancer. This means they haven't had any other treatments for their prostate cancer before joining the study. The second group is for men whose prostate cancer has come back after previous treatment, and they are now having brachytherapy (either a high-dose or pulsed-dose type) to treat the recurring cancer. For this second group, it's important that they haven't had any radiation therapy in the three months leading up to this new brachytherapy, and they shouldn't have had their prostate gland surgically removed in the past (prostatectomy).

However, some men won't be able to join the study. This includes those who have an existing autoimmune disease (where the body's immune system mistakenly attacks itself), those taking blood-thinning medicines, or those with a history of substance abuse.

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 with prostate cancer?
Are you scheduled to have brachytherapy for your prostate cancer?
If this is your first treatment, have you had no previous prostate cancer treatments?
If your cancer has returned, have you not had any radiation in the last 3 months and not had your prostate removed?
Do you not have an autoimmune disease or take blood thinners?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have blood samples taken at specific times: before your brachytherapy treatment begins, at some point during your treatment, and again after your treatment is finished. If your brachytherapy involves collecting tissue samples, these will also be used for the study. The exact number of visits for blood draws and the total duration of your participation will depend on your treatment schedule. You won't need to take any new medication specifically for the study. The study aims to look at how your immune system changes as a result of your standard brachytherapy treatment.

Potential risks and benefits

Taking part in this study won't directly treat your cancer, as it involves collecting samples from treatments you'd be having anyway. However, the information gathered could help future patients by improving our understanding of how brachytherapy works with the immune system. The main risks involve the discomfort and small bruising from regular blood tests. As with any study, you are free to change your mind and withdraw at any time without giving a reason, and this will not affect your standard medical care.

Locations (3)

Klinik für Strahlentherapie
Verified postcode
Augsburg, Germany· Not yet recruiting
Strahlenklinik Erlangen
Verified postcode
Erlangen, Germany· Recruiting
Klinik und Poliklinik für Strahlentherapie und Radioonkologie
Verified postcode
Munich, Germany· Not yet recruiting

Common questions

What is brachytherapy?

Brachytherapy is a type of radiation treatment for prostate cancer where small radioactive 'seeds' are placed directly into the prostate gland to kill cancer cells.

What are immune biomarkers?

These are simply signs in your blood or tissues that tell us about the activity of your body's immune system – your natural defence against disease.

Will taking part in this study change my cancer treatment?

No, this study is observing your immune system during the brachytherapy treatment you would already be receiving. It won't change your planned cancer care.

Will I get results from my individual immune tests?

The study focuses on understanding general patterns across many patients. Individual results are usually not given back to participants.

How long will I be involved in the study?

Your involvement depends on your brachytherapy schedule, as samples will be taken before, during, and after your treatment.

How to find out more

Claudia Schweizer, MD

claudia.schweizer@uk-erlangen.de +49 9131 85 33968 Official trial record

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