RecruitingOBSERVATIONAL

Liquid Biopsy Under PSMA Radioligand Therapy

This study focuses on advanced prostate cancer that has spread and is resistant to standard hormone treatments. A new treatment called PSMA Radioligand Therapy (PSMA-RLT) targets specific prostate cancer cells. While often effective initially, the cancer can return quickly, and we don't fully understand why. Researchers are using 'liquid biopsies,' which are simple blood tests, to collect information before, during, and after PSMA-RLT. Unlike traditional tissue samples, blood tests are less invasive and can be done many times. By looking at things like circulating tumour DNA (ctDNA) in the blood, the study aims to predict how well the treatment will work, assess its effectiveness, and uncover why some cancers become resistant to PSMA-RLT. This could lead to better ways to manage the disease.

At a glance

Status

Recruiting

Sponsor

Wuerzburg University Hospital

Enrolment target

100

Start

01 Sep 2024

Estimated completion

01 Aug 2028

Prostate Cancer Metastatic Castration-Resistant Prostate Cancer

What is this study about?

When prostate cancer spreads and stops responding to hormone therapy, it's called metastatic castration-resistant prostate cancer (mCRPC). For some men with this type of cancer, a special treatment called PSMA Radioligand Therapy (PSMA-RLT) is an option. This treatment uses a radioactive substance that specifically targets prostate cancer cells, aiming to kill them.

While PSMA-RLT can work well at first, sometimes the cancer starts to grow again quite quickly. Doctors don't yet fully understand why this happens. This study wants to use a new approach called 'liquid biopsy' to learn more. A liquid biopsy is a simple blood test, much like a regular blood draw, and it's a lot easier on the patient than taking a piece of tissue (a traditional biopsy).

By taking these blood samples before, during, and after PSMA-RLT, researchers hope to find out a few key things. They want to see if specific markers in the blood can predict how well a patient will respond to the treatment. They also want to use these blood tests to monitor if the treatment is working and, importantly, to discover why some cancer cells become resistant to PSMA-RLT over time. This information could eventually help doctors make better treatment decisions and develop new ways to fight this aggressive form of prostate cancer.

Key takeaways

This study uses blood tests (liquid biopsies) to understand advanced prostate cancer.
It focuses on prostate cancer that has spread and no longer responds to hormone therapy.
The goal is to learn how a treatment called PSMA-RLT works and why it sometimes stops being effective.
Researchers hope to find new ways to predict treatment success and monitor its effects.
Participation involves additional blood samples alongside your standard care.

Who may be eligible?

This study is for men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. You would need to be approved for PSMA-RLT treatment by your doctors and have recently had a special scan called a PSMA PET/CT.

To be included, you must have tried at least one type of anti-hormone treatment and one chemotherapy treatment (taxane-based therapy) in the past. You also need to be at least 18 years old and be willing to provide written consent to join the study. If you don't speak German, you'll need a translator.

However, you wouldn't be able to join if you're not willing to follow the study's procedures or if your doctors haven't recommended PSMA-RLT for you after discussing it at a special meeting (a tumour conference).

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.

I have prostate cancer that has spread and is resistant to hormone therapy.
I am approved for PSMA Radioligand Therapy (PSMA-RLT).
I have had a PSMA PET/CT scan recently (within 8 weeks).
I have tried at least one anti-hormone treatment and one chemotherapy (taxane) before.
I am 18 years old or older.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the PSMA-RLT treatment as planned by your doctors. Throughout your treatment, you would have regular 'liquid biopsies,' which are blood tests taken at different times: before, during, and after your PSMA-RLT. This allows researchers to track changes over time. Your regular clinic appointments and imaging scans (like your PSMA PET/CT) will continue as usual, and the clinical information from these will also be used in the study. All of this will happen at one of the participating hospitals.

Potential risks and benefits

Taking part in this study means doctors will be able to collect more information about your cancer and how it responds to PSMA-RLT, potentially helping to improve future treatments for others. This could lead to a better understanding of why the treatment works for some and not for others. The main risk involved is the extra blood tests, which are generally safe but may cause minor discomfort or bruising. There are no additional medications or procedures beyond your planned PSMA-RLT. You are free to stop participating in the study at any time without affecting your medical care.

Locations (3)

University hospital Wuerzburg - Department of Nuclear Medicine
Verified postcode
Augsburg, Germany· Recruiting
TUM Klinikum rechts der Isar - Department of Nuclear medicine
Verified postcode
München, Germany· Recruiting
University hospital Wuerzburg - Department of Nuclear Medicine
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is a 'liquid biopsy'?

A liquid biopsy is a simple blood test that can find tiny pieces of cancer cells or their DNA shed into your bloodstream from the tumour.

What is PSMA-RLT?

PSMA-RLT is a special treatment for advanced prostate cancer that uses a radioactive substance to target and kill cancer cells.

Why is this study important?

This study aims to understand why PSMA-RLT sometimes stops working and to find better ways to monitor treatment effectiveness, which could help future patients.

Are there any extra medicines involved in this study?

No, this study does not involve any extra medicines. You will receive your PSMA-RLT treatment as planned by your doctors.

Will my regular prostate cancer care change if I join?

No, your regular medical care for prostate cancer will not change. You will still receive all your planned treatments and check-ups.

How to find out more

Kerstin Michalski, MD

michalski_k@ukw.de +4993120135931 Official trial record

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