Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer
Launched by NOVARTIS PHARMACEUTICALS · Mar 27, 2023
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the long-term safety of a treatment called lutetium (177Lu) vipivotide tetraxetan, also known as AAA617, in men with prostate cancer. The goal is to learn more about any potential risks or side effects that might occur over time after patients have received this treatment during earlier clinical trials. Researchers want to ensure that the treatment remains safe for patients in the long run, especially those who have already received it.
To participate in this study, men aged 65 to 74 who have received at least one dose of AAA617 in a previous Novartis-sponsored trial can take part. They must agree to follow certain guidelines, like using condoms during sexual activity for up to 14 weeks after their last treatment. Participants will undergo various assessments to monitor their health and any effects from the treatment. This study is currently recruiting participants and aims to gather important information that can help improve care for future prostate cancer patients.
Gender
MALE
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.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Rochester, Minnesota, United States
Cleveland, Ohio, United States
New Orleans, Louisiana, United States
Jacksonville, Florida, United States
New Orleans, Louisiana, United States
Scottsdale, Arizona, United States
Hartford, Connecticut, United States
Bronx, New York, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Delft, , Netherlands
Maastricht, , Netherlands
Madrid, , Spain
Sutton, Surrey, United Kingdom
Athens, Georgia, United States
Hospitalet De Llobregat, Catalunya, Spain
Essen, , Germany
Barcelona, Catalunya, Spain
Gent, , Belgium
Sabadell, Barcelona, Spain
Wien, , Austria
Rostock, , Germany
Goteborg, , Sweden
Lyon, , France
Glasgow, , United Kingdom
Omaha, Nebraska, United States
Linz, , Austria
Valencia, , Spain
Cambridge, , United Kingdom
Stockholm, , Sweden
Muenchen, , Germany
Middlesbrough, , United Kingdom
Fort Wayne, Indiana, United States
Barnet, , United Kingdom
Houston, Texas, United States
Praha 5, , Czechia
Athens, Georgia, United States
Montreal, Quebec, Canada
Pittsburgh, Pennsylvania, United States
Santa Monica, California, United States
Olomouc, Cze, Czechia
Hartford, Connecticut, United States
Jacksonville, Florida, United States
Fort Wayne, Indiana, United States
Saint Louis, Missouri, United States
Durham, North Carolina, United States
Olomouc, , Czechia
Dallas, Texas, United States
Rochester, Minnesota, United States
Nijmegen, , Netherlands
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Orange, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Royal Oak, Michigan, United States
Jackson, Mississippi, United States
Omaha, Nebraska, United States
Bronx, New York, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Roanoke, Virginia, United States
Omaha, Nebraska, United States
Orange, California, United States
Royal Oak, Michigan, United States
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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