177Lu-HTK03170 in mCRPC With PSMA Positive Disease
This study is looking for men with advanced prostate cancer that has spread to other parts of the body and is not responding to hormone treatment. It's testing a new radioactive drug called 177Lu-HTK03170. The main goal is to find the safest starting dose of this drug and see how well it works. Researchers will carefully monitor how the drug travels through the body and how much radiation different organs receive. They will also check if the cancer shrinks, measure different cancer markers, and see how the treatment affects quality of life. Participants will have up to five cycles of treatment, with regular check-ups for up to two years.
At a glance
What is this study about?
This study is designed for men who have advanced prostate cancer that has spread to other parts of their body and is no longer being controlled by standard hormone treatments. This type of cancer is called 'metastatic castration-resistant prostate cancer' (mCRPC). The study is testing a new treatment called 177Lu-HTK03170. This drug is a 'radioligand therapy,' which means it combines a special protein that targets cancer cells with a small amount of radiation. The idea is for the drug to deliver radiation directly to the cancer cells, hopefully shrinking them while limiting harm to healthy cells.
The main purpose of this study is to find the safest starting dose of this new radioactive drug. Researchers will give small, carefully measured doses and closely monitor how the drug behaves in the body and how much radiation different organs receive. This process, called 'dosimetry,' helps them understand the best and safest way to give the treatment. They will gradually increase the dose in some patients until they find the highest dose that is still considered safe. They also want to see if this new drug can help shrink the cancer and improve the patient's condition.
Beyond finding the right dose, the study will also look at how effective the treatment is. This includes checking if the cancer shrinks using scans, measuring levels of cancer markers in the blood (like PSA), and looking at genetic material from the cancer. Participants will also be asked to complete questionnaires to see how the treatment affects their quality of life. The study plans to follow participants for up to two years, or until their cancer progresses and they need to switch to a different treatment.
Key takeaways
- This study tests a new radioactive drug for advanced prostate cancer.
- It's for men whose cancer has spread and isn't responding to hormone therapy.
- The main goals are to find the safest dose and see if the drug shrinks cancer.
- Participation involves injections of the drug, scans, blood tests, and questionnaires.
- You'll be monitored for up to two years, or until your cancer progresses.
Who may be eligible?
To join this study, we're looking for men who are at least 18 years old and have advanced prostate cancer that has spread. This cancer must have shown signs of getting worse despite previous hormone treatments like abiraterone or enzalutamide. You might also be eligible if you've had certain chemotherapy treatments or other targeted therapies.
It's important that your overall health is good enough to handle the treatment, which means your organs like your bone marrow, kidneys, and liver need to be working reasonably well. Your doctor will do blood tests to check this. You also need to have significant cancer showing up on special scans called PSMA PET/CT scans, which confirms the cancer can be targeted by the study drug.
There are also some things that would prevent you from joining. For example, if your general health isn't strong enough, or if you have other serious medical conditions that might make the study treatment unsafe for you. Your blood tests must meet certain levels, and you must have shown clear signs that your prostate cancer is progressing, either through rising PSA levels or changes on scans.
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?
- Do you have prostate cancer that has spread and is no longer responding to hormone treatment?
- Has your cancer recently shown signs of getting worse (e.g., rising PSA, changes on scans)?
- Are your kidney, liver, and blood count tests generally within healthy limits?
- Are you able to visit the clinic regularly for treatments and check-ups?
What does participation involve?
If you join this study, your journey will start with a 'screening phase' to make sure you're eligible. This involves meeting the study doctor, filling out a health questionnaire, having a physical exam, getting blood tests, and having a special PSMA PET/CT scan to confirm your cancer is suitable for this treatment. You'll also have a standard CT scan.
If you qualify, you will then receive up to five cycles of the study drug, 177Lu-HTK03170. Each treatment cycle will involve receiving an injection of the study drug. After each injection, you will have several follow-up scans (SPECT/CT scans) over a few days to see how the radiation is distributed in your body. The amount of drug you receive might change slightly in later cycles based on these scans to make sure it's as safe and effective as possible.
Throughout the study, you'll have regular check-ups, which include physical exams, blood tests, and scans (CT scans, PSMA PET/CT scans) to monitor your cancer and overall health. You will also complete questionnaires about your quality of life. This follow-up will continue for up to two years, or until your cancer gets worse and you need to switch to another treatment.
Potential risks and benefits
Locations (1)
- BC CancerVerified postcodeVancouver, Canada
Common questions
What kind of cancer is this study for?
This study is for men with advanced prostate cancer that has spread and is no longer responding to hormone therapy.
What is 177Lu-HTK03170?
It's a new radioactive drug being tested. It's designed to deliver radiation directly to prostate cancer cells.
How often will I receive treatment?
You could receive up to 5 treatment cycles, with specific timing determined by the study doctors after each cycle.
Will I have a lot of tests?
Yes, you will have regular blood tests, physical exams, and scans (like CT and special PET scans) to monitor your health and the cancer.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, and your medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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