AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Clinical study to evaluate the safety and efficacy of a new targeted radioactive drug treatment for advanced prostate cancer

This study is testing a new type of treatment for men with advanced (metastatic) prostate cancer, meaning cancer that has spread to other parts of the body. The medicine is a targeted radioactive drug. It is designed to travel through the bloodstream and stick directly to prostate cancer cells, delivering radiation straight to the tumours while trying to spare healthy tissue. This is a Phase 1 trial, which means it is the very first time this treatment is being tested in humans. The main goal is not yet to prove a cure, but to make sure the drug is safe to use. Doctors want to find the best and safest dose, learn what side effects occur, and see how the body handles the drug. Taking part involves close monitoring, hospital visits, scans, and regular blood tests.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Fondazione IRCCS Istituto Nazionale Dei Tumori

Enrolment target

Start

15 Sep 2026

Metastatic prostate cancer

What is this study about?

Prostate cancer begins in the prostate gland, which sits below the bladder in men. In some cases, cancer cells break away and spread to other areas, such as the bones or lymph nodes. This is known as advanced or metastatic prostate cancer. When cancer reaches this stage, doctors usually offer treatments like hormone therapy or chemotherapy to keep it under control and manage symptoms.

Researchers are now developing targeted radioactive drugs. You can think of this medicine like a guided missile. One part of the drug searches for and attaches to a specific marker found on prostate cancer cells. The other part carries a tiny amount of radiation. Once attached, it delivers radiation directly into the cancer cell to damage or destroy it, helping to limit harm to the surrounding healthy cells.

Because this is a Phase 1 study, it is the first time doctors are giving this medicine to people. The primary focus is learning how safe the treatment is, identifying any side effects, and finding the correct dose. While doctors hope the treatment helps control the cancer, the main purpose is to gather crucial information to see if this medicine can become a safe treatment option in the future.

Key takeaways

This is an early-stage study testing a new targeted radioactive drug for advanced prostate cancer.
This is the first time the medicine is being tested in human patients.
The primary aim is to test safety, find the best dose, and monitor side effects.
The study is for adult men whose cancer has spread to other parts of the body.
Participation is entirely voluntary, and you can withdraw at any point.

Who may be eligible?

This trial is open to adult men aged 18 and over who have been diagnosed with advanced or metastatic prostate cancer. This usually means the cancer has spread beyond the prostate gland to other parts of the body.

Because it is an early-stage safety trial, it is often intended for people whose cancer is no longer responding well to standard NHS treatments. Before joining, the study team will carry out a thorough health check to make sure the trial is suitable and safe for you.

You may not be eligible if you have other serious medical conditions, such as severe heart or kidney problems, or if your blood counts are outside safe levels. Your specialist will review your full medical history and recent scans to see if you qualify.

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 a man aged 18 or older.
I have been diagnosed with advanced or metastatic prostate cancer.
My cancer has spread or is no longer responding to standard treatments.
I am well enough to attend regular hospital appointments for tests and scans.
I am interested in trying a new, experimental treatment.

Answer every question to see your result.

What does participation involve?

Taking part in this trial involves receiving the new medicine at a specialist hospital, usually as an injection or through a drip into a vein. Because it is a radioactive drug, you may need to stay in the hospital clinic for a short period of observation afterwards so the medical team can monitor your radiation levels and check for any immediate side effects. The study team will explain simple safety precautions you might need to take around family members for a short time after each dose.

Throughout the study, you will have regular hospital visits. These will include blood tests, physical checks, and imaging scans (such as CT, MRI, or bone scans) to track how your body and your cancer respond. The trial may last several months, followed by regular check-ins to monitor your health over the longer term.

Potential risks and benefits

The potential benefit of joining this study is the possibility that the new drug may help slow or shrink your cancer, and you will contribute to research that could help other men in the future. However, because this drug is brand new to humans, there are risks. You may experience unexpected side effects, tiredness, nausea, or changes in your blood cell counts. The treatment may also not work for your cancer. Taking part is completely your choice. You are free to leave the trial at any time, and doing so will not affect your relationship with your medical team or the standard of care you receive.

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 1 clinical trial?

A Phase 1 trial is the very first step in testing a new medicine in people. Its main goal is to find out if the drug is safe, what dose is best, and what side effects it might cause.

Will I become radioactive to other people?

Targeted radioactive treatments give off small amounts of radiation for a short time. The clinical team will give you clear, simple instructions on how to stay safe around family, pets, and children.

Does taking part cost anything?

No, the study medicine and all trial-related tests are provided free of charge. In many cases, help with travel expenses to and from the hospital is available.

Will this drug cure my prostate cancer?

It is unlikely to be a cure. The main goals of early trials are to check safety and see if the drug can help control the cancer and manage symptoms.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without giving a reason. Your doctors will continue to give you the best available standard NHS care.