Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
This research is looking at a new treatment called 177Lu-rhPSMA-10.1 for men with prostate cancer that has spread and is no longer responding to standard hormone treatments. This type of cancer is known as metastatic castration-resistant prostate cancer (mCRPC). The treatment uses a special radioactive substance designed to find and destroy prostate cancer cells. This study has two parts: Phase 1 will work out the best dose and check for safety, while Phase 2 will further test its effectiveness and safety in more men. We're hoping to find a new way to treat this advanced form of prostate cancer, especially for those whose disease has progressed after previous therapies.
At a glance
What is this study about?
This study is investigating a new treatment for men with a type of prostate cancer that has spread to other parts of the body and is no longer controlled by hormone therapy. This is called metastatic castration-resistant prostate cancer (mCRPC). We know that living with advanced prostate cancer can be challenging, and researchers are always looking for better ways to fight it. This new treatment, called 177Lu-rhPSMA-10.1, uses a clever technique where a radioactive substance (Lutetium-177) is attached to a molecule that specifically targets prostate cancer cells (PSMA). This means the treatment can deliver radiation directly to the cancer cells, hopefully causing less harm to healthy parts of the body.
The study has two main stages. The first stage, Phase 1, is about finding the right dose of the treatment and making sure it's safe. A small number of men will take part in this stage. Doctors will carefully monitor how the treatment affects them and how much radiation reaches the cancer. Once they have a better understanding of the dose and safety, they'll move on to Phase 2. This larger stage will involve more men and will focus on how well the treatment works to shrink or control the cancer, as well as continuing to keep a close eye on safety.
Both stages of the study are for men whose prostate cancer has continued to grow despite previous treatments. This includes men who have had specific hormone-blocking drugs (like abiraterone or enzalutamide). Some men in Phase 1 will also have had chemotherapy, while men in Phase 2 will not have had chemotherapy before entering the study. This careful approach helps researchers understand how the new treatment works in different situations, aiming to offer a new option for men who need it.
Key takeaways
- This study tests a new targeted radiation treatment (177Lu-rhPSMA-10.1) for advanced prostate cancer.
- It's for prostate cancer that has spread and is no longer responding to standard hormone therapy.
- The treatment specifically targets cancer cells with a marker called PSMA.
- There are two phases: one to find the right dose and ensure safety, and another to test how well it works.
- Participation involves injections, regular check-ups, and scans.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you must be a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. Your prostate cancer must have spread and no longer respond to hormone therapy. We'll need to check your blood to make sure your hormone levels are low enough and that your body's systems (like your bones and other organs) are working well enough for you to take part. Important for this study is that your cancer cells must show a specific marker called PSMA, which we'll check with a special scan.
Your cancer must have continued to grow despite previous treatments. This means you would have likely had certain hormone-blocking drugs. If you're joining Phase 1, you would also have had one or two rounds of chemotherapy. If you're joining Phase 2, you would not have had chemotherapy for your advanced prostate cancer yet. You should also feel generally well, able to carry out most of your normal daily activities, and doctors will check that any side effects from previous treatments have mostly cleared up.
You cannot join the study if you are allergic to the study medications or if scans show that a significant part of your cancer doesn’t have the PSMA marker. Also, if your scans show that your bone marrow is too affected by the cancer, you might not be able to participate. There are also specific timeframes that need to pass since your last cancer treatment or major surgery before you can start the study.
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 with confirmed prostate cancer?
- Has your prostate cancer spread and is it resistant to hormone therapy?
- Do your cancer cells show the PSMA marker on special scans?
- Have you had previous treatments for your prostate cancer that are no longer working?
- Do you generally feel well enough for most daily activities (ECOG 0-2)?
- Are you able to use adequate contraception for yourself and your partner?
What does participation involve?
If you join this study, you'll receive the new treatment, 177Lu-rhPSMA-10.1, through an injection. If you're in Phase 1, you'll also have an additional scan using 18F-rhPSMA-7.3 to help doctors understand more about the treatment.
During the study, you'll have regular visits to the hospital for examinations, blood tests, and scans (like CT, MRI, and special PSMA scans). These appointments are to monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These follow-up appointments will continue after your treatment is finished to track your progress. The total length of your participation will depend on the study phase and how you respond to treatment, but involves multiple visits over several months.
Potential risks and benefits
Locations (21)
- Biogenix Molecular LLCVerified postcodeMiami, United States· Recruiting
- NovaCure HealthVerified postcodeMiami, United States· Recruiting
- Emory University HospitalVerified postcodeAtlanta, United States· Recruiting
- XCancer Omaha / Urology Cancer CenterVerified postcodeOmaha, United States· Recruiting
- Weill Cornell Medicine - New York - Presbyterian HospitalVerified postcodeNew York, United States· Completed
- Saint Luc University HospitalVerified postcodeBrussels, Belgium· Recruiting
- University Hospital GhentVerified postcodeGhent, Belgium· Recruiting
- University Hospital LeuvenVerified postcodeLeuven, Belgium· Recruiting
- University Hospital AachenVerified postcodeAachen, Germany· Recruiting
- Universitätsklinikum AugsburgVerified postcodeAugsburg, Germany· Recruiting
- University Hospital EssenVerified postcodeEssen, Germany· Recruiting
- Hospital Rechts der IsarVerified postcodeMunich, Germany· Recruiting
Common questions
What is PSMA?
PSMA (prostate-specific membrane antigen) is a protein found in large amounts on the surface of most prostate cancer cells. This study's treatment is designed to target cells that have PSMA.
What is hormone-resistant prostate cancer?
This is prostate cancer that continues to grow even when hormone-blocking treatments are used to lower your testosterone levels.
What is Lutetium-177?
Lutetium-177 is a mildly radioactive substance that is used to deliver radiation directly to cancer cells that have the PSMA marker.
Will I receive chemotherapy in this study?
If you are in Phase 1, you would have already had chemotherapy. If you are in Phase 2, you will not have had chemotherapy for your advanced prostate cancer before joining the study.
What are the common side effects?
The study team will discuss all possible side effects with you, as reactions can vary. These are often related to the radiation and could affect bone marrow or other organs.
How to find out more
Blue Earth Therapeutics
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.