Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I study to evaluate the safety and dosimetry of 68Ga-OncoACP3 in patients with prostate cancer

This is an early research study (Phase I) looking into a new type of imaging scan called 68Ga-OncoACP3. The main goal is to check if this new scan is safe for men with prostate cancer and to understand how it behaves in the body. Researchers want to see if it can effectively detect prostate cancer, particularly when the cancer might have spread (metastasised), returned after treatment, or if doctors are considering a specific type of targeted treatment called 177Lu-labelled PSMA ligands. This study is the first time this particular scan is being used in people, so it's a very early step in understanding its potential.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Philogen S.p.A.

Enrolment target

Start

27 Nov 2024

a progressive and confirmed serum PSA level > 0.2 ng/mL) -metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands

What is this study about?

Imagine doctors are trying to find hidden treasure, and they need a new, more powerful map. This study is similar: researchers are trying out a new special map, a type of scan called 68Ga-OncoACP3, to help them find prostate cancer cells in the body. This is a very early stage of research, called a Phase I study, which means it's the first time this specific scan is being tested in people. The main goals are to make sure it's safe and to understand how it behaves once it's in the body, for example, how long it stays there and where it goes.

Why is this important? Prostate cancer can sometimes spread to other parts of the body, or it can come back after treatment. It's really important for doctors to know exactly where the cancer is so they can give the best possible treatment. This new scan might help doctors get a clearer picture in situations like when they suspect the cancer has spread, when blood tests show the cancer might have returned, or when they are considering a specific type of advanced treatment for prostate cancer.

By participating, you'd be helping scientists understand if this new scan could be a valuable tool in the future for diagnosing and managing prostate cancer. Even though it's an early study, learning how this scan works in people is a crucial step towards potentially making it available to more patients down the line.

Key takeaways

This is an early-stage study (Phase I) testing a new prostate cancer scan.
The main goals are to check safety and how the scan works in the body.
It aims to find prostate cancer that may have spread or returned.
Participants must be men aged 18+ with specific prostate cancer conditions.
This study is for research and does not offer cancer treatment.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for men who have been diagnosed with prostate cancer. You need to be at least 18 years old to take part.

Specifically, the study is interested in men whose prostate cancer falls into one of these categories: either your doctors suspect your cancer might have spread and you're planning your first main treatment; or your blood tests (PSA levels) suggest your prostate cancer may have come back after earlier treatment; or you have prostate cancer that has spread, and your doctors are considering a particular type of treatment that involves something called 177Lu-labelled PSMA ligands.

The research team will carefully review your medical history and test results to see if you meet all the specific requirements to join this study. They will explain everything clearly to you.

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 prostate cancer?
Do your doctors suspect your prostate cancer has spread and you're about to start your first significant treatment?
Or, have your blood tests (PSA) risen, suggesting your prostate cancer has returned?
Or, do you have prostate cancer that has spread, and your doctors are considering a specific treatment called 177Lu-labelled PSMA ligands?

Answer every question to see your result.

What does participation involve?

As this is an early-stage study, taking part would mainly involve receiving the new imaging agent (68Ga-OncoACP3) and undergoing the scans to see how it works. You would likely have a few appointments for screening tests, receiving the study agent, and then having the necessary scans. There might be some follow-up appointments or phone calls to check on your well-being after the scan. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but generally, Phase I studies focus on carefully monitoring participants over a relatively short period.

Potential risks and benefits

Participating in any clinical study has potential benefits and risks. A potential benefit of this study is that you would receive a new type of scan that might provide more detailed information about your prostate cancer than standard scans. This information could be useful for your doctors, although the primary goal of this study is research, not direct treatment. The main risks are those associated with receiving a new substance in your body, such as potential side effects or allergic reactions, as well as risks from the scanning procedures themselves (like exposure to a small amount of radiation, similar to other medical scans). You will be closely monitored for any reactions. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is a Phase I study?

It's the very first stage of testing a new treatment or scan in people. The main goals are to check if it's safe and how it works in the body.

What is a 'scan' in this study?

It's an imaging test, similar to an X-ray or MRI, but it uses a special substance to create detailed pictures inside your body to help doctors see prostate cancer cells.

What does 'metastasis' mean?

It means the cancer has spread from where it started (the prostate gland) to other parts of your body.

What is a PSA level?

PSA stands for Prostate-Specific Antigen, which is a protein produced by the prostate. High or rising levels in a blood test can suggest prostate cancer might be present or returning.

Will this study treat my cancer?

No, this study is primarily focused on testing a new diagnostic scan, not providing treatment. Any information gained might help your doctors guide your future treatment decisions.