NCT07450157

A Study of Patient Characteristics, Treatment Patterns and Outcomes Among Patients Treated With 177Lu-PSMA-617

Patient Characteristics, Treatment Patterns and Outcomes Among Early Adopters of 177Lu-PSMA-617: An Early View Claims Data Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,448 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate patient characteristics, treatment patterns, prostate-specific antigen (PSA) reduction, and overall survival (OS) of prostate cancer patients treated with 177-Lutetium-Prostate-Specific Membrane Antigen-617 (177Lu-PSMA-617). Patient data from multiple electronic health record databases, including claims (open-source medical and pharmacy claims), consumer attributes, mortality, and laboratory data linked to claims databases was used. The study analysis was conducted in two phases. Phase I provided an early view of patients treated with 177Lu-PSMA-617 shortly after launch. Phase II refreshed the data, added mortality and extracted additional years of historical data to allow for the identification of the initial metastatic castrate-resistant prostate cancer (mCRPC) diagnosis and follow-up from that date through the start of 177Lu-PSMA-617.

Conditions

• Prostate Cancer

Timeline

• Start date: 2023-06-23
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States