Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AAA617.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Canada, Czechia +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IV, Post-Authorization Safety Study to Investigate the Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Adult Participants With Prostate Cancer
Overview
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.
Detailed description
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.
Interventions
- Drug AAA617
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.
Primary outcome measures
- Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study]
Secondary outcome measures (2)
- Number and percentage of participants who have died [Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study]
- Absorbed radiation dose in kidney or other selected organs and number of AEs [Time frame: every visit up to 10 years after 1st dose of AAA617 received in parent treatment study]
Eligibility criteria
Inclusion criteria
- Signed informed consent must be obtained prior to participation in the study
- Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.
Exclusion criteria
\- Inability to complete the needed investigational examinations due to any reason.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 24 centers
- Mayo Clinic Arizona — Scottsdale
- St. Joseph Hospital — Orange
- Providence Saint Johns Health Ctr — Santa Monica
- University of Colorado — Aurora
- Hartford Hospital — Hartford
- VA Medical Center — Washington D.C.
- Mayo Clinic Jacksonville — Jacksonville
- University Cancer and Blood Center LLC — Athens
- … and 16 more centers
Spain · 10 centers
- Novartis Investigative Site — L'Hospitalet de Llobregat
- Novartis Investigative Site — Sabadell
- Novartis Investigative Site — Majadahonda
- Novartis Investigative Site — Barcelona
- Novartis Investigative Site — Barcelona
- Novartis Investigative Site — Madrid
- Novartis Investigative Site — Madrid
- Novartis Investigative Site — Madrid
- … and 2 more centers
United Kingdom · 5 centers
- Novartis Investigative Site — Sutton
- Novartis Investigative Site — Barnet
- Novartis Investigative Site — Cambridge
- Novartis Investigative Site — Glasgow
- Novartis Investigative Site — Middlesbrough
Germany · 3 centers
- Novartis Investigative Site — Essen
- Novartis Investigative Site — München
- Novartis Investigative Site — Rostock
Netherlands · 3 centers
- Novartis Investigative Site — Nijmegen
- Novartis Investigative Site — Maastricht
- Novartis Investigative Site — Delft
Austria · 2 centers
- Novartis Investigative Site — Linz
- Novartis Investigative Site — Vienna
Czechia · 2 centers
- Novartis Investigative Site — Olomouc
- Novartis Investigative Site — Prague
Sweden · 2 centers
- Novartis Investigative Site — Gothenburg
- Novartis Investigative Site — Stockholm
Belgium · 1 center
- Novartis Investigative Site — Ghent
Canada · 1 center
- Novartis Investigative Site — Montreal
France · 1 center
- Novartis Investigative Site — Lyon
Identifiers
NCT: NCT05803941 · CAAA617A12402 · 2023-503208-94-00