At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AAA617 (drug)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- AAA617 — drug: Long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from parent interventional Novartis sponsored clinical trials.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the long-term safety of a drug called lutetium (177Lu) vipivotide tetraxetan in people with prostate cancer. It is run by Novartis Pharmaceuticals. It is for people who have already had at least one dose of this drug (called AAA617 in trials) as part of an earlier Novartis study.
Who can take part
- You have signed a form agreeing to take part (informed consent)
- You have had at least one dose of AAA617 in an earlier Novartis-sponsored prostate cancer trial (phase I to IV)
- You met the requirements of that earlier trial that allow you to join this study
Who may not be able to
- You cannot complete the study tests and checks for any reason
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- Male
- Number of participants
- 700
- Started
- 2023-08-14
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • Phase4 - 700 participants
- • The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with prostate cancer
- • Male only
Where?
- • Sutton - Novartis Investigative Site
- • Barnet - Novartis Investigative Site
- • Cambridge - Novartis Investigative Site
- • Glasgow - Novartis Investigative Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
More detail
This is a global, prospective, multi-center, long-term follow-up (LTFU) safety study of adult participants with prostate cancer that have received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials. There will be no study treatment administered to participants in this study. Participants will have visits every 6-8 months for monitoring of selected AEs and laboratory parameters. The study periods include a Baseline and Follow-up Period (up to 10 years after first dose of AAA617 in parent treatment study). Participants should enroll into the LTFU study after parent treatment study requirements are fulfilled (refer to the parent treatment study protocol for requirements, including any additional requirements after participant enters this LTFU safety study). The schedule of activities for this LTFU study is designed to start from date of informed consent for this LTFU study. Participants should be followed every 6 to 8 months for up to a total of 10 years starting from first dose of AAA617 in the parent treatment study. Participants entering the LTFU study will have already completed a variable portion of the required 10-year follow-up within the parent treatment study. The specific number of visits required in this LTFU study will depend upon the time of enrollment into this LTFU study following the first dose of AAA617 in the parent treatment study. The total number of participants to be enrolled and the duration of this LTFU study will depend upon the total number treated in the parent treatment studies and their duration.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: Male only
What the study is looking for
- ✓Signed agreement to take part must be obtained prior to participation in the study
Who cannot take part
- ✗\- Inability to complete the needed investigational examinations due to any reason.
See the full criteria
Where Is This Study? (5 UK sites)
Novartis Investigative Site
Sutton SM2 5PT, United Kingdom
Novartis Investigative Site
Barnet EN5 3DJ, United Kingdom
Novartis Investigative Site
Cambridge CB2 0QQ, United Kingdom
Novartis Investigative Site
Glasgow G12 0YN, United Kingdom
Novartis Investigative Site
Middlesbrough TS4 3BW, United Kingdom
How to Get in Touch
Novartis Pharmaceuticals
Sponsor contactCONTACT
Novartis Pharmaceuticals
Sponsor contactCONTACT