TheranosticTrials.org

Clinical Trial · NCT07450157

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

Overview

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.

Sponsor

Novartis

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT07450157

Drug / Compound

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • ≥12 months of continuous data availability prior to the mCRPC diagnosis date.
  • Patients with ≥1 PSA result available on or within 6 months prior to the index date. The PSA result closest to the index date was defined as the baseline PSA level.
  • Patients with ≥1 claim in the open-source medical claims data with a Healthcare Common Procedure Coding System (HCPCS) code of A9607 or ≥1 claim in the open-source medical or pharmacy claims data with a National Drug Code (NDC) code for 177Lu-PSMA-617 during the patient selection window. The date of the first such claim is the index date.
  • Patients with ≥1 PSA result available after the index date.Phase II inclusion criteria:
  • Evidence of castration resistance observed during the study period. The date of mCRPC diagnosis was defined as the latest of the date of metastasis and the date of castration resistance and must have occurred during the index window.

Exclusion

Exclusion criteria not yet provided.