A single-arm pilot study to investigate tumor absorbed dose dynamics and feasibility of pre-treatment dosimetry with [177Lu]-PSMA-I&T in male participants aged ≥ 18 years with metastatic castration-resistant prostate cancer
This clinical trial is testing a targeted treatment called 177Lu-PSMA-I&T for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. 177Lu-PSMA-I&T works like a homing missile. It attaches directly to prostate cancer cells and delivers a small dose of radiation to destroy them while sparing healthy tissue as much as possible. The main goal of this study is to measure the exact amount of radiation absorbed by tumours during treatment. By carrying out detailed scans before and after therapy, researchers hope to see how the medicine moves through the body. The trial also tracks changes in tumour size and checks for any side effects. Gathering this information could help doctors design more personalised and effective treatments for men with advanced prostate cancer in the future.
At a glance
What is this study about?
Prostate cancer often relies on male hormones to grow. Standard treatments usually block these hormones, but over time, the cancer can adapt and start growing again. When prostate cancer spreads to other parts of the body and stops responding to hormone therapy, it is known as metastatic castration-resistant prostate cancer. Finding new ways to target these hard-to-treat cancer cells is an urgent focus of medical research.
This trial is investigating a medicine called 177Lu-PSMA-I&T. Most prostate cancer cells have a unique protein on their surface called PSMA. This treatment uses a molecule designed to lock onto PSMA, carrying a small radioactive particle called Lutetium-177 straight to the tumour. The goal is to attack the cancer cells from the inside while causing minimal damage to surrounding healthy cells.
A central focus of this study is measuring radiation absorption, a process called dosimetry. Just as shoe sizes vary, every person's tumours absorb radiation differently. By scanning patients before and after treatment, doctors can measure the exact dose of radiation reaching the tumours. Understanding this could allow doctors in the future to tailor radiation doses to each patient, improving treatment success while keeping side effects as low as possible.
Key takeaways
- The trial tests a targeted radioactive treatment called 177Lu-PSMA-I&T for advanced prostate cancer.
- It focuses on measuring the exact dose of radiation that reaches the tumours.
- The study is for men aged 18 and over whose cancer has spread and resists hormone therapy.
- All participants receive the study medicine; there is no placebo.
- Participation is voluntary and includes close health monitoring and regular scans.
Who may be eligible?
This study is open to adult men aged 18 and over who have been diagnosed with metastatic castration-resistant prostate cancer. This means the cancer has spread beyond the prostate gland and is no longer held in check by standard hormone-lowering treatments.
Because this treatment targets a specific marker on cancer cells, participants usually need scans showing that their tumours carry the PSMA protein. Patients must also be well enough to attend hospital visits and undergo regular imaging scans.
Men may not be eligible if they have serious medical conditions affecting their kidneys, liver, or bone marrow, or if they have recently received certain other cancer treatments. The study team will review each person's medical history to ensure taking part is as safe as possible.
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 has continued to grow despite standard hormone therapy.
- I am well enough to travel to hospital visits and lie still for scans.
- I am willing to undergo regular blood tests and imaging.
What does participation involve?
Taking part in this study involves receiving 177Lu-PSMA-I&T as an injection or drip into a vein. Before and after receiving the medicine, you will have specialised imaging scans, such as PET scans, to measure how the drug travels through your body and how much radiation your tumours absorb. You will also have regular blood tests, physical examinations, and check-ups to monitor your general health and track any side effects. The study includes several hospital visits over a number of months, followed by routine check-ins so the medical team can see how you are doing over time.
Potential risks and benefits
Locations (1)
- —UnverifiedNorway
Common questions
What is 177Lu-PSMA-I&T?
It is a targeted cancer medicine that combines a molecule that seeks out prostate cancer cells with a small radioactive substance to destroy them from within.
What does dosimetry mean?
Dosimetry is the science of measuring the exact amount of radiation absorbed by tumours and normal organs during treatment.
Will I receive a dummy treatment (placebo)?
No. This is a single-arm study, meaning all participants who take part will receive the active study medicine.
Is the radiation dangerous to my family?
The radiation stays mostly inside your body and fades quickly, but the clinical team will give you simple safety advice, such as keeping a short distance from young children and pregnant women for a few days.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any point without giving a reason, and it will not affect the quality of your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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