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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07450157
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 23, 2023
Status verified
Feb 2026
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
6,448 participants (actual)

Arms

  • Arm: 177Lu-PSMA-617 Patients Meeting Minimum Study Criteria
    Phase I analysis group. Adult patients treated with 177Lu-PSMA-617 who met the minimum study criteria.
  • Arm: 177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available
    Phase I analysis group. Adult patients who met the minimum study criteria and had at least one PSA result available 28 days or more after the index date (177Lu-PSMA-617 initiation) while still on 177Lu-PSMA-617 treatment.
  • Arm: Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period
    Phase II analysis group. Adult patients with mCRPC who initiated 177Lu-PSMA-617 between 01 July 2014 and 30 September 2024 (index period).
  • Arm: Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment)
    Phase II analysis group. Adult patients with continuous enrollment (CE) between the mCRPC diagnosis date and initiating 177Lu-PSMA-617 (index date), and at least 6 months of CE prior to the index date.

Primary Outcome Measure

Number of Patients by Demographic Category [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
NovartisEast HanoverNew Jersey07936-

Find similar trials in East Hanover, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Novartis· East Hanover, NJ

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