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NCT07843758

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

View on ClinicalTrials.gov

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

Locations (1)

Novartis

Basel, Switzerland