Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Tolerability of concurrent EBRT + Lu-PSMA for node-positive prostate cancer (PROQURE-1)

This research study, called PROQURE-1, is for men with prostate cancer. Specifically, it's for those where the cancer has spread to the lymph nodes close to the prostate but hasn't spread further to distant parts of the body (N+M0 prostate cancer). The main goal of this study is to find out if giving two cancer treatments together is safe and if people can handle the side effects. These treatments are external beam radiation therapy (EBRT), which is a common type of radiation, and a newer treatment called Lu-PSMA. Lu-PSMA is a type of targeted radiation that finds and attacks prostate cancer cells. This is a very early-stage study, meaning it's one of the first times this combination is being tested in people. All participants will be adult men aged 18 or older.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Enrolment target

Start

23 May 2024

N+M0 prostate cancer

What is this study about?

This study, named PROQURE-1, is exploring a new way to treat prostate cancer. Prostate cancer often responds well to treatment, but it can sometimes spread. This study is specifically for men whose prostate cancer has spread to their lymph nodes (small bean-shaped glands that are part of the body's immune system) near the prostate, but not to other distant parts of the body. This is important because treating cancer that has spread to lymph nodes can be challenging, and researchers are looking for more effective approaches.

The study combines two types of radiation treatment: external beam radiation therapy (EBRT) and Lu-PSMA. EBRT is a well-known treatment where radiation is delivered from outside the body to kill cancer cells. Lu-PSMA is a newer, more targeted approach. It involves injecting a small amount of radioactive material that is designed to specifically attach to prostate cancer cells, wherever they are in the body, and deliver radiation directly to them. The idea behind combining these treatments is to see if they can work better together to fight the cancer.

This is a 'Phase I' study, which means it's one of the very first times this specific combination of treatments is being tested in humans. The main purpose at this stage is to check how safe it is and how well people can tolerate the treatments when given at the same time. Researchers are carefully looking for any side effects and trying to find the best way to give these treatments together.

Key takeaways

This study is for men with prostate cancer that has spread to nearby lymph nodes, but not elsewhere.
It combines two radiation treatments: external beam radiation and Lu-PSMA.
The main goal is to check the safety and tolerability of this new combination.
It's a Phase I study, meaning it's an early look at this treatment approach.
Participation involves receiving the treatments and regular follow-up appointments.

Who may be eligible?

This study is open to adult men who have been diagnosed with prostate cancer. A key requirement is that your cancer must have spread to the lymph nodes close to the prostate. However, it's very important that scans have confirmed the cancer has *not* spread to any other distant parts of your body, such as your bones or other organs.

You must be at least 18 years old to be considered for this study. As this is a medical study, there will be other specific health checks and tests to make sure that the treatment is safe for you and that you meet all the necessary medical criteria. This includes reviewing your overall health, other medical conditions, and any previous treatments you've had.

Your cancer doctor will be able to tell you if your specific situation matches these requirements. It's always best to discuss with them if you are interested in learning more about participating.

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 am an adult male (aged 18 or older).
I have been diagnosed with prostate cancer.
My cancer has spread to my lymph nodes near the prostate.
My doctors have confirmed my cancer has *not* spread to distant parts of my body.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive a combination of two cancer treatments: external beam radiation therapy (EBRT) and a special type of internal radiation therapy called Lu-PSMA. You would have regular appointments at the hospital for these treatments and for monitoring your health.

This would involve a number of visits for the EBRT sessions, typically over several weeks, and separate visits for the Lu-PSMA treatment, which is usually given as an injection. There would also be several check-up appointments before, during, and after the treatments. These check-ups will include physical examinations, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.

After your treatments are completed, you would likely have follow-up appointments over a longer period to see how you are doing in the long term. The total length of your participation, including treatments and follow-up, would be fully explained by the study team. You would receive all information about the specific schedule and what to expect at each stage.

Potential risks and benefits

Like all medical treatments, especially in a research study, there are potential benefits and potential risks. The potential benefit of taking part in this study is that you might gain access to a new combination of treatments that could be more effective for your type of prostate cancer than standard options, though this is not guaranteed. You would also be contributing valuable information that could help other patients in the future. However, there are also potential risks. Combining these treatments might lead to new or more intense side effects than either treatment alone. The study team will closely monitor you for any side effects, which they will explain in detail. You are free 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.

—
Unverified
Netherlands

Common questions

What does N+M0 prostate cancer mean?

N+M0 prostate cancer means the cancer has spread to the lymph nodes near the prostate (N+), but it hasn't spread to distant parts of the body (M0).

What is external beam radiation therapy (EBRT)?

EBRT is a common cancer treatment that uses beams of high-energy radiation directed from outside the body to destroy cancer cells in a specific area.

What is Lu-PSMA?

Lu-PSMA is an internal radiation treatment. A small amount of radioactive material is given, which travels to prostate cancer cells and delivers radiation directly to them.

Why are they combining these two treatments?

Researchers want to see if giving EBRT and Lu-PSMA together is safe and if it could be a more effective way to treat specific types of prostate cancer.

Is this a new treatment?

While both EBRT and Lu-PSMA are used individually, this study is testing the *combination* of these two treatments given at the same time. This is a very early, Phase I study, so it's a new approach being investigated.