Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer
Launched by NOVARTIS PHARMACEUTICALS · Jul 18, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the real-world use of a treatment called lutetium (177Lu) vipivotide tetraxetan for men with metastatic castration-resistant prostate cancer (mCRPC). This type of cancer has spread to other parts of the body and has not responded to traditional hormone therapies. The goal of the study is to understand how this treatment affects the quality of life for patients, both while they are receiving the treatment and after their cancer progresses.
To be eligible for this trial, participants must be adult men aged 18 or older who have been diagnosed with mCRPC and are starting treatment with lutetium as prescribed by their doctor. They need to provide written consent to participate and agree to share information about their quality of life for a year after starting treatment. It's important to note that patients cannot be involved in any other clinical trials at the same time. Those who join can expect to regularly report on their health and well-being during the study period, helping researchers learn more about the treatment's real-world effects.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- All patients must meet the following inclusion criteria during the identification period:
- • Adult male patients diagnosed with mCRPC and initiating lutetium (177Lu) vipivotide tetraxetan by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of Cycle 1.
- • ≥ 18 years old at the time of enrollment
- • Written informed consent must be obtained prior to any data collection
- • Willing to participate in Quality of Life post treatment date collection for 1 year
- Exclusion Criteria:
- Patients must not meet the following exclusion criterion during the identification period:
- • - Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan
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
Trier, , Germany
Ulm, , Germany
Regensburg, Bavaria, Germany
Essen, , Germany
Jena, , Germany
Tuebingen, , Germany
Bonn, , Germany
Wuerzburg, , Germany
Aachen, , Germany
Magdeburg, , Germany
Chemnitz, , Germany
Berlin, , Germany
Augsburg, , Germany
Bielefeld, , Germany
Halle S, , Germany
Konstanz, Baden Wuerttemberg, Germany
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported