Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase I study of neoadjuvant treatment with 177-Lutetium-PSMA-617 with Ipilimumab in subjects with very high-risk prostate cancer who are candidates for radical prostatectomy (NEPI Trial)

This study is for men with very high-risk prostate cancer who are planning to have surgery to remove their prostate. It's called a Phase I study, which means it's one of the first times this specific combination of treatments is being tested in humans. The study aims to see if giving two medicines, Ipilimumab and Pluvicto (which is a targeted radiation treatment), before surgery is safe and if it helps surgeons remove the cancer. Researchers will carefully monitor participants for any side effects and see if the treatments help shrink the cancer. The main goal is to make sure surgery can still be performed effectively and safely after these pre-surgery treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Universitaetsklinikum Essen AöR

Enrolment target

Start

31 Jul 2024

What is this study about?

This research study, called the NEPI Trial, is looking into a new approach for men diagnosed with very high-risk prostate cancer. When cancer is considered 'very high-risk,' it often means it's more advanced, has a higher chance of spreading, or is growing more quickly. In these situations, doctors often recommend surgery to remove the prostate gland, which is called a radical prostatectomy.

What makes this study different is that it's testing whether giving two specific treatments before surgery can improve the outcome. These treatments are Ipilimumab, a type of medicine that helps your body's immune system fight cancer, and Pluvicto, which is a targeted radiation treatment designed to deliver radiation directly to prostate cancer cells. The idea is that by shrinking or weakening the cancer before surgery, it might make the surgery more successful or reduce the chances of the cancer coming back.

This is a 'Phase I' study, which means it's mainly focused on safety. Researchers want to find out if giving these treatments together before surgery is well-tolerated and doesn't cause too many serious side effects. They will also look at whether the treatments make it possible to perform the surgery as planned and if they have any effect on the cancer itself, such as making it smaller or less aggressive. By answering these questions, the study aims to pave the way for better treatments for men with very high-risk prostate cancer in the future.

Key takeaways

This study tests two new treatments before prostate cancer surgery.
It's for men with very high-risk prostate cancer.
The main focus is on safety and whether surgery can still be done.
Treatments include immune therapy (Ipilimumab) and targeted radiation (Pluvicto).
You'll have regular checks throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is specifically for men aged 18 or older who have been diagnosed with very high-risk prostate cancer. This means your doctors have determined your cancer is advanced based on specific tests, such as your Gleason score (a way to grade how aggressive the cancer cells look), the size of your tumour, whether lymph nodes are affected, or your PSA level (a blood test).

To be considered for this study, you must also be a candidate for a radical prostatectomy, which is an operation to remove your prostate gland, along with the nearby lymph nodes. This indicates that your doctors believe surgery is a suitable treatment option for you.

There might be other health requirements or conditions that would make someone unsuitable for the study, and these would be discussed in detail by the study team if you express interest. It's important to talk to your doctor to see if your specific situation fits all the study's requirements.

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?
Have you been diagnosed with very high-risk prostate cancer?
Are you scheduled or a candidate for prostate removal surgery (radical prostatectomy)?
Have your doctors confirmed your Gleason Score, tumour stage, or PSA level meets the very high-risk criteria?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two types of treatment before your planned prostate surgery: Ipilimumab and Pluvicto. The study team will explain exactly how these treatments are given, which usually involves injections or infusions over a set period. You will have regular appointments and tests, including blood tests and scans, to monitor your health and how the treatments are affecting you and your cancer. This monitoring is crucial to make sure the treatments are safe and to see if they are working.

After you have completed the pre-surgery treatments, your doctors will aim to perform your prostatectomy as planned, usually within about 85 days from the start of the treatment. There might be a small delay of up to three weeks if needed. After your surgery, you will have follow-up appointments and tests to check your recovery and to see if the cancer has been successfully removed or reduced. The study will also track your progress, particularly your PSA levels, for at least one year after surgery. The total duration you'd be involved in the study, including follow-up, will be clearly outlined by the research team.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit of this study is that the combination of Ipilimumab and Pluvicto before surgery might help shrink your cancer, potentially making your surgery more successful or reducing the chance of the cancer returning. However, as this is a new combination, it also carries potential risks, such as side effects from the medications. The research team will carefully monitor you for any adverse effects using standard medical scales. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. Weighing these potential benefits and risks with your doctor is a crucial step before deciding to participate.

Locations (1)

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

—
Unverified
Germany

Common questions

What is 'very high-risk prostate cancer'?

This means your cancer is more advanced, with a higher chance of spreading or growing quickly, based on specific medical tests like your Gleason score and PSA level.

What are Ipilimumab and Pluvicto?

Ipilimumab is a type of medicine that helps your immune system fight cancer. Pluvicto is a targeted radiation treatment that aims to deliver radiation directly to prostate cancer cells.

What does 'neoadjuvant treatment' mean?

It means the treatment is given before the main treatment, which in this case is prostate removal surgery (radical prostatectomy), with the aim of improving the surgery's outcome.

What is the main goal of this study?

The main goal is to find out if giving Ipilimumab and Pluvicto before prostate surgery is safe and if it allows the surgery to be performed effectively.

Will my doctors know if I have very high-risk prostate cancer?

Yes, your doctors use specific medical criteria and test results to determine if your prostate cancer is classified as very high-risk.