All studies
RecruitingPHASE4INTERVENTIONAL

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

Status
Recruiting
Phase
PHASE4
Sponsor
Novartis Pharmaceuticals
Enrolment target
700
Start
14 Aug 2023
Estimated completion
21 Jul 2033

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.

  1. I have prostate cancer.
  2. I have previously received the AAA617 treatment in a research study.
  3. I have completed all requirements for that previous study.
  4. I am aged between 18 and 100 years old.
  5. I am a man (due to the focus on prostate cancer).
Answer every question to see your result.

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

The main benefit of joining this study is that you would be contributing vital information to medical science, which will help doctors and researchers better understand the long-term safety of AAA617 for future prostate cancer patients. Since no new treatment is given, the direct risks are generally low, focusing mainly on potential inconvenience from follow-up visits and blood tests. However, as with any medical study, there's always a chance that unexpected health issues could arise or be identified during monitoring. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic Arizona
    Verified postcode
    Scottsdale, United States· Recruiting
  • St. Joseph Hospital
    Verified postcode
    Orange, United States· Recruiting
  • Providence Saint Johns Health Ctr
    Verified postcode
    Santa Monica, United States· Recruiting
  • University of Colorado
    Verified postcode
    Aurora, United States· Recruiting
  • Hartford Hospital
    Verified postcode
    Hartford, United States· Recruiting
  • VA Medical Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Mayo Clinic Jacksonville
    Verified postcode
    Jacksonville, United States· Recruiting
  • University Cancer and Blood Center LLC
    Verified postcode
    Athens, United States· Recruiting
  • Parkview Research Center
    Verified postcode
    Fort Wayne, United States· Recruiting
  • Tulane Cancer Center
    Verified postcode
    New Orleans, United States· Recruiting
  • Ochsner Clinic Foundation
    Verified postcode
    New Orleans, United States· Recruiting
  • Corewell Health William Beaum Hosp
    Verified postcode
    Royal 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?

Register your interest

Share your details and the research team for "Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan i…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.