AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase II, single arm two-phase, clinical study of individually adapted systemic radioligand therapy with 177Lu-PSMA I&T for patients with metastatic, castration-resistant prostate cancer

This clinical trial is testing a targeted treatment called 177Lu-PSMA for men with advanced prostate cancer. When prostate cancer spreads to other areas of the body and no longer responds to standard hormone treatments, doctors look for new ways to keep it under control. The study medicine works like a tiny guided missile. It travels through the bloodstream, latches onto a specific marker found on prostate cancer cells, and delivers a small dose of radiation straight into the tumour to damage it from within. In this Phase II study, doctors adjust the treatment to fit each person's specific needs. Researchers will track whether the treatment shrinks tumours, lowers a key cancer marker in the blood called PSA, and delays the cancer from getting worse. They will also look at whether it helps relieve bone pain and improves general wellbeing.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Region Uppsala

Enrolment target

Start

12 Aug 2026

Prostate cancer

What is this study about?

Prostate cancer often relies on hormones to grow. Standard treatments work by blocking these hormones, but over time, the cancer cells can learn to grow anyway. When the cancer continues to grow and spread to other parts of the body, such as the bones, it is known as metastatic castration-resistant prostate cancer. At this stage, doctors need more targeted tools to fight the disease.

This trial is exploring a type of treatment called radioligand therapy, using a medicine named 177Lu-PSMA. Most prostate cancer cells have high amounts of a specific protein on their surface called PSMA. The study drug binds directly to this protein. Attached to it is a small amount of radioactive material that delivers radiation right to the cancer cell. The aim is to damage or destroy the cancer while causing less harm to surrounding healthy tissues.

What makes this study special is that doctors are tailoring the treatment plan to each individual patient rather than giving everyone the exact same schedule. They will use specialised PET and CT scans to take pictures of the cancer and watch how it responds over time.

By taking part, patients help doctors learn whether this personalised approach can help men live longer without their cancer progressing. Researchers also want to find out if it reduces cancer-related pain, protects bones from damage, and helps maintain a good quality of life.

Key takeaways

The trial tests a targeted radiation treatment (177Lu-PSMA) for advanced prostate cancer that has stopped responding to hormone therapy.
The medicine delivers radiation directly into cancer cells using a specific protein target.
Treatment doses and timing are adapted to how each individual's cancer responds.
The main goals are to slow cancer growth, lower PSA levels, and improve pain and quality of life.
Taking part is voluntary, and you can leave the study at any time without affecting your usual care.

Who may be eligible?

This trial is for men aged 18 and older who have advanced prostate cancer. To take part, the cancer must have spread to other parts of the body (such as the bones or lymph nodes) and must still be growing even after receiving standard hormone-lowering treatments.

Doctors will run tests to confirm whether the cancer cells show the target protein (PSMA) on special scans. If the tumours do not show enough of this target, the medicine will not be able to find and treat them effectively.

Because safety comes first, patients must have reasonably good general health and acceptable kidney, liver, and bone marrow function. The study team will review each person's medical history and current medications to make sure the treatment is safe for them.

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 (metastatic) prostate cancer.
My cancer is still growing or spreading despite receiving hormone therapy.
I am well enough to attend regular hospital appointments and scans.
I am willing to receive treatment through a vein and follow simple safety instructions.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves several stages over a number of months. First, you will attend a screening appointment where the study team will carry out health checks, blood tests, and specialised imaging scans (such as PET/CT scans) to confirm if the trial is right for you.

If you join, the study medicine is given through a drip directly into a vein. Because the treatment uses a radioactive substance, you will receive clear safety guidance on what to do for a short time afterwards, such as drinking plenty of fluids and keeping a small distance from young children and pregnant women.

Throughout the study, you will have regular hospital visits for blood tests to measure your PSA levels and check your organ function. You will also have periodic scans to see how your tumours are responding, and the team will ask you questions about your energy levels, daily activities, and any pain you might feel. After finishing the treatment, doctors will continue to check in on your health at scheduled follow-up visits.

Potential risks and benefits

This trial may help shrink your tumours, lower your PSA levels, and reduce bone pain, but there is no guarantee it will work for everyone. The information gathered will also help improve future treatments for other men with advanced prostate cancer. However, the treatment can cause side effects. Common ones include fatigue, dry mouth, nausea, and temporary drops in blood cell counts, which can increase the risk of infection or bruising. You are free to stop taking part at any time without giving a reason, and doing so will not affect your normal NHS care or relationship with your medical team.

Locations (1)

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

—
Unverified
Sweden

Common questions

What is radioligand therapy?

It is a targeted treatment that combines a homing molecule with a tiny amount of radiation. The molecule seeks out and attaches to cancer cells, delivering radiation straight to the tumour while sparing most healthy tissue.

Will I be radioactive after receiving the treatment?

The medicine leaves a very low level of radiation in your body for a short time. Most of it leaves through your urine in the first day or two. The hospital team will give you simple, practical precautions to protect those around you.

What is PSA and why is it measured?

PSA stands for prostate-specific antigen. It is a protein made by prostate cells and can be measured with a simple blood test. A dropping PSA level often suggests that treatment is working against the cancer.

Do I have to pay to take part in this trial?

No. The trial medication and all extra study-related tests are provided at no cost. Many trials also offer support with travel expenses to and from hospital visits.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw at any point, and your standard cancer care will continue as normal.