Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
This research study is designed to carefully watch the long-term safety of a prostate cancer treatment known as AAA617. We're inviting people who have already taken part in earlier research studies involving AAA617 to participate. The main goal is to understand any potential side effects that might appear over a longer period, even years after they first received the treatment. This is important because some effects can take time to show up. This study will not involve giving you any new treatment; instead, it focuses on monitoring your health over time to gather crucial information for patients in the future. We want to make sure we have a complete picture of the treatment's safety profile.
At a glance
What is this study about?
This study is all about understanding the long-term safety of a treatment for prostate cancer called AAA617. If you have prostate cancer and have previously received AAA617 as part of another research study, this new study is designed for you. We already know a lot about AAA617, but sometimes, the full picture of a treatment's effects, especially any potential side effects, takes many years to become clear.
The main aim here is to keep a close eye on people who've had AAA617 to see if any new health concerns or side effects develop a long time after their treatment. This is really important because it helps doctors and researchers understand the full impact of AAA617 over many years. Your participation would help us gather valuable information that will ultimately benefit future patients with prostate cancer.
It's important to remember that this isn't a treatment study. You won't be given any new medication or treatment as part of this study. Instead, it's about checking in with you regularly to see how you're doing and to learn more about your long-term health after receiving AAA617.
Key takeaways
- This study tracks the long-term safety of prostate cancer treatment AAA617.
- It's for men who previously received AAA617 in a research study.
- No new treatment is given; it's purely for monitoring your health over time.
- You'll have check-ups every 6-8 months for up to 10 years.
- Your participation helps improve future care for prostate cancer patients.
Who may be eligible?
To be part of this study, you must have previously taken part in another research study for prostate cancer where you received at least one dose of the treatment called AAA617. You would also need to have completed all the requirements of that previous study, making you eligible for this follow-up.
Before joining, you'll need to sign a consent form, which means you understand and agree to take part. You must be an adult, aged between 18 and 100 years old, and this study is specifically for men, as it focuses on prostate cancer.
There are very few reasons why you might not be able to join. The main exclusion is if for any reason you wouldn't be able to complete the necessary health checks and examinations required by 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.
- I have prostate cancer.
- I have previously received the AAA617 treatment in a research study.
- I have completed all requirements for that previous study.
- I am aged between 18 and 100 years old.
- I am a man (due to the focus on prostate cancer).
What does participation involve?
If you decide to join this study, you won't receive any new treatment for your prostate cancer. Instead, we'll be checking in with you every 6 to 8 months. During these visits, we will monitor certain health markers and conduct laboratory tests to see how you are doing over time. These visits are to look for any known or potential side effects of the AAA617 treatment you received in an earlier study.
The study aims to follow you for up to 10 years in total, starting from the very first dose of AAA617 you received in your original treatment study. The number of visits you'll need for this specific follow-up study will depend on how long it's been since your first AAA617 dose when you join. Some of the 10-year follow-up might have already been covered within your previous study. The total duration of the study depends on how many participants there are and how long their earlier treatment studies lasted.
Potential risks and benefits
Locations (54)
- Mayo Clinic ArizonaVerified postcodeScottsdale, United States· Recruiting
- St. Joseph HospitalVerified postcodeOrange, United States· Recruiting
- Providence Saint Johns Health CtrVerified postcodeSanta Monica, United States· Recruiting
- University of ColoradoVerified postcodeAurora, United States· Recruiting
- Hartford HospitalVerified postcodeHartford, United States· Recruiting
- VA Medical CenterVerified postcodeWashington D.C., United States· Recruiting
- Mayo Clinic JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- University Cancer and Blood Center LLCVerified postcodeAthens, United States· Recruiting
- Parkview Research CenterVerified postcodeFort Wayne, United States· Recruiting
- Tulane Cancer CenterVerified postcodeNew Orleans, United States· Recruiting
- Ochsner Clinic FoundationVerified postcodeNew Orleans, United States· Recruiting
- Corewell Health William Beaum HospVerified postcodeRoyal Oak, United States· Recruiting
Common questions
What is AAA617?
AAA617 is a specific treatment for prostate cancer that you would have received in a previous research study.
Will I get medication in this study?
No, this study does not involve giving you any new medication or treatment. It's purely for long-term health monitoring.
How often will I have appointments?
You will have check-up visits approximately every 6 to 8 months.
How long will I be in the study?
You will be followed for up to 10 years, starting from your very first dose of AAA617 in your earlier treatment study.
What kind of checks will be done?
We will monitor certain health markers and run laboratory tests during your visits to see how you are doing.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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