Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 9:15 PM
Study NCT ID:
NCT07450157
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Patient Characteristics, Treatment Patterns and Outcomes Among Patients Treated With 177Lu-PSMA-617
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Patient Characteristics, Treatment Patterns and Outcomes Among Early Adopters of 177Lu-PSMA-617: An Early View Claims Data Study
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: