RecruitingRecruiting
Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
NCT05803941 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
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.
Study design
Enrollment target: 700 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-08-14
Estimated completion: 2033-07-21
Last updated: 2026-06-04
Interventions
Drug: AAA617
Primary outcomes
- • Number and percentage of participants with selected Adverse Events (AEs) and Serious Adverse Events (SAEs) (every visit up to 10 years after 1st dose of AAA617 received in parent treatment study)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (54)
Mayo Clinic ArizonaRecruiting
Scottsdale, Arizona, United States
St. Joseph HospitalRecruiting
Orange, California, United States
Providence Saint Johns Health CtrRecruiting
Santa Monica, California, United States
University of ColoradoRecruiting
Aurora, Colorado, United States
Hartford HospitalRecruiting
Hartford, Connecticut, United States
VA Medical CenterRecruiting
Washington D.C., District of Columbia, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
University Cancer and Blood Center LLCRecruiting
Athens, Georgia, United States
Parkview Research CenterRecruiting
Fort Wayne, Indiana, United States
Tulane Cancer CenterRecruiting
New Orleans, Louisiana, United States
Ochsner Clinic FoundationRecruiting
New Orleans, Louisiana, United States
Corewell Health William Beaum HospRecruiting
Royal Oak, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
University of Mississippi Med CtrRecruiting
Jackson, Mississippi, United States
Wash U School of MedicineRecruiting
St Louis, Missouri, United States
Urology Cancer Center PCRecruiting
Omaha, Nebraska, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Univ of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Univ of Texas Southwest Med CenterRecruiting
Dallas, Texas, United States
UT Health Science CenterRecruiting
Houston, Texas, United States
Onco Hemato Asso of SW VirginiaRecruiting
Roanoke, Virginia, United States
Novartis Investigative SiteRecruiting
Linz, Austria
Novartis Investigative SiteRecruiting
Vienna, Austria
Novartis Investigative SiteRecruiting
Ghent, Belgium
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
Novartis Investigative SiteRecruiting
Olomouc, Czechia
Novartis Investigative SiteRecruiting
Prague, Czechia
Novartis Investigative SiteRecruiting
Lyon, France
Novartis Investigative SiteRecruiting
Essen, Germany
Novartis Investigative SiteRecruiting
München, Germany
Novartis Investigative SiteRecruiting
Rostock, Germany
Novartis Investigative SiteRecruiting
Nijmegen, Gelderland, Netherlands
Novartis Investigative SiteRecruiting
Maastricht, Limburg, Netherlands
Novartis Investigative SiteRecruiting
Delft, South Holland, Netherlands
Novartis Investigative SiteRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative SiteRecruiting
Sabadell, Barcelona, Spain
Novartis Investigative SiteRecruiting
Majadahonda, Madrid, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Madrid, Spain
Novartis Investigative SiteRecruiting
Valencia, Spain
Novartis Investigative SiteRecruiting
Gothenburg, Sweden
Novartis Investigative SiteRecruiting
Stockholm, Sweden
Novartis Investigative SiteRecruiting
Sutton, Surrey, United Kingdom
Novartis Investigative SiteRecruiting
Barnet, United Kingdom
Novartis Investigative SiteRecruiting
Cambridge, United Kingdom
Novartis Investigative SiteRecruiting
Glasgow, United Kingdom
Novartis Investigative SiteRecruiting
Middlesbrough, United Kingdom