NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
This study is exploring a new type of treatment for prostate cancer that has spread and changed into a faster-growing type called neuroendocrine prostate cancer. It uses special scans to identify specific markers, like 'signposts', on the surface of cancer cells. Once these signposts are found, the study delivers a targeted radiation treatment designed to stick to these markers and destroy the cancer cells, while hopefully sparing healthy tissues. The main goal is to understand how safe and effective this targeted radiation therapy is. Researchers will also look at how these markers on the cancer cells change during treatment. This could help doctors personalise treatments in the future, choosing the best approach for each patient.
At a glance
What is this study about?
This study is for men with prostate cancer that has spread beyond the prostate, and has developed into a more aggressive type called neuroendocrine prostate cancer. This kind of cancer can sometimes be harder to treat with standard methods, so new approaches are needed.
The study uses an advanced technique called 'targeted radioligand therapy'. Imagine cancer cells have personalised 'postcodes' on their surface. This treatment uses special imaging scans to find these specific postcodes. Once found, a small amount of radioactive medicine is attached to a molecule that can deliver it directly to these cancer cells. This is a very precise way to target the cancer, aiming to damage the cancer cells themselves while being gentler on healthy parts of the body.
The main aim of this study is to see how safe this new treatment is and how well it works in men with this type of prostate cancer. Researchers will also examine how the 'postcodes' on the cancer cells change over time, which could help them understand how the treatment is working and develop even better ways to fight this disease in the future. This is a Phase 1 study, meaning it's one of the first times this specific approach is being tested in people, so the focus is on understanding safety and initial effects.
Key takeaways
- This study is testing a new, targeted radiation treatment for a specific, aggressive type of prostate cancer.
- It uses special scans to find specific 'markers' on cancer cells before treatment.
- Treatment involves up to six doses of targeted radiation, given through a drip every six weeks.
- The main goals are to check the treatment's safety and how well it works.
- You would have regular check-ups and scans to monitor your health and the treatment’s effects.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
To join this study, you need to be a man, aged between 18 and 100, and have prostate cancer that has spread and shown signs of becoming neuroendocrine cancer. Doctors will check this using biopsies or blood tests, looking for specific changes related to this type of prostate cancer.
You also need to have certain 'markers' (like signposts) on your cancer cells that can be seen on special scans. These markers are important because they are what the targeted treatment will attach to. Your general health should be good enough to take part in the study, and any side effects from previous treatments must have settled down.
You cannot join if you've had similar targeted radiation treatments before, or certain other types of radiation treatment in the last six months. Also, if your cancer has spread to your brain or spinal cord and is causing significant problems, or if you're undergoing other cancer treatments at the same time, you wouldn't be able to participate.
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 to 100?
- Do you have prostate cancer that has spread and shown signs of becoming neuroendocrine type?
- Have you had recent scans or tests that show specific 'markers' on your cancer cells?
- Is your general health good enough to take part in a study?
- Have you avoided certain types of radiation treatments in the last six months?
- Are you able to attend regular hospital appointments for scans and treatments?
What does participation involve?
If you join this study, you would first have special full-body scans to look for specific markers on your cancer cells. These scans use a small amount of a radioactive tracer that helps the doctors see where the cancer is and what type of markers it has. Based on these scans, a specific targeted radiation treatment will be chosen for you.
During treatment, you would receive up to six doses of this targeted radiation therapy, given through a drip into your vein. Each dose would be given about every six weeks. You would also receive other standard medications like those to help with nausea or to manage hormone levels, as needed. After receiving your first treatment, you'll need to have follow-up scans a few weeks later to see how the treatment is affecting the cancer.
Throughout the study, which could last up to 36 weeks (about 8 months), you’ll have regular check-ups with the study team to monitor your health and any side effects. After the treatment period, there will be a final safety check-up after about six weeks. You can stop participating in the study at any time.
Potential risks and benefits
Locations (9)
- Nebraska Cancer SpecialistsVerified postcodeOmaha, United States
- Memorial Sloan Kettering Cancer CtrVerified postcodeNew York, United States
- Novartis Investigative SiteVerified postcodeNantes, France
- Novartis Investigative SiteVerified postcodeMünchen, Germany
- Novartis Investigative SiteVerified postcodeRostock, Germany
- Novartis Investigative SiteVerified postcodeL'Hospitalet de Llobregat, Spain
- Novartis Investigative SiteVerified postcodeMadrid, Spain
- Novartis Investigative SiteVerified postcodeSutton, United Kingdom
- Novartis Investigative SiteVerified postcodeLondon, United Kingdom
Common questions
What exactly is neuroendocrine prostate cancer?
It's a rare and aggressive type of prostate cancer where the cancer cells have changed and started to grow and behave differently from typical prostate cancer.
What does 'targeted radioligand therapy' mean?
It means using a special treatment that has a small amount of radiation attached, which is designed to go directly to and stick to cancer cells, aiming to destroy them.
How often will I need to visit the hospital?
You'll have initial scans, then up to six treatment visits every six weeks, and follow-up scan visits and check-ups with the study team, over a period of up to 36 weeks.
Will I know if the treatment is working for me?
The study team will use follow-up scans and perform regular checks to monitor your progress and will discuss any changes with you.
What if I feel unwell during the study?
The study team will monitor you closely for any side effects and will be available to answer your questions and provide care throughout your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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