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An External Control Arm Study Comparing Survival Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With 177Lu-PSMA-617 vs Androgen Receptor Pathway Inhibitor (ARPI) Switch in Routine Care
Sponsor: Novartis Pharmaceuticals
Summary
The aim of this study is to assess the effectiveness of 177Lu-PSMA-617 (lutetium (177Lu) vipivotide tetraxetan) on survival in patients randomized to receive treatment following progression on one ARPI from the PSMAfore trial compared to the effectiveness of a change in ARPI treatment on survival in a real-world setting in patients with mCRPC who are taxane-naive but have progressed after a switch in ARPI.
Official title: Comparing the Lutetium (177Lu) Vipivotide Tetraxetan Arm of the PSMAfore Clinical Trial to a Switch in Androgen Receptor Pathway Inhibitor (ARPI) as External Control Arm (ECA) Using a Real-world Data Source for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Progression on Prior ARPI
Key Details
Gender
MALE
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
1525
Start Date
2024-03-01
Completion Date
2025-10-01
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Locations (1)
Novartis
Basel, Switzerland