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

First listed
Mar 4, 2026
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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