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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Actual): 6448

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with electronic health care records in multiple databases who were treated with 177Lu-PSMA-617.

Description

Phase I inclusion criteria:

1. 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.
2. For patients identified via NDC code, ≥1 claim with one of the following procedure codes on the same date as the 177Lu-PSMA-617 NDC claim: HCPCS - A9699, J3590; CPT 79191; or ≥1 claim with HCPCS code A9595 or A9597 occurring within 14 days before or after the index date.
3. At least 18 years of age at index date.

4. Patients with ≥2 medical claims ≥180 days prior to the index date.

   For the treatment response analysis, the following additional criteria were applied:

5. Patients with linkage to lab data.
6. 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.
7. Patients with ≥1 PSA result available after the index date.

Phase II inclusion criteria:

1. ≥2 medical claims (≥30 days apart) with a diagnosis of prostate cancer observed during the patient selection period.
2. ≥1 medical claim with a diagnosis code for metastatic disease occurring on or after the first observed prostate cancer diagnosis. The date of the first such claim was defined as the date of metastasis.
3. 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.
4. ≥12 months of continuous data availability prior to the mCRPC diagnosis date.
5. ≥1 claim for 177Lu-PSMA-617 after mCRPC diagnosis and continuous data availability between diagnosis and the date of 177Lu-PSMA-617 initiation.

Exclusion criteria

1. Standard data cleaning processes were applied to remove patients with data quality issues. Specific data quality issues included missing or invalid age or sex.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients by Demographic Category	Demographics included: Age group; Geographical region; Payer type; Physician specialty; Race/ethnicity; Education level; Occupation	Baseline
Number of Patients by Clinical Characteristic Category	Clinical characteristics included: National Cancer Institute (NCI) comorbidity index; NCI category; Comorbidities; Metastasis sites; Number of distinct metastatic sites; PSA level category (≤ 4 ng/ml, > 4 ng/ml)	Baseline
Clinical Characteristic: Baseline PSA Level		Baseline
Overall Survival (OS)	OS was defined as the time from mCRPC diagnosis until death.	Up to approximately 10 years
Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date		6, 12, 24, and 36 months
Survival Time After the Last Administration of 177Lu-PSMA-617		Up to approximately 10 years
Number of Patients who Died After the Last Administration of 177Lu-PSMA-617		Up to approximately 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617		Up to approximately 10 years
Percentage of Patients by Line of 177Lu-PSMA-617 Initiation		Up to approximately 10 years
Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment		Baseline
Duration of Each Line of Treatment (LOT) by Treatment Received		Up to approximately 10 years
Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617		Up to approximately 10 years
177Lu-PSMA-617 Treatment Duration		Up to approximately 10 years
Percentage of Patients Still on 177Lu-PSMA-617 Therapy at 3, 6, 9, and 12 Months After Initiation of 177Lu-PSMA-617		3, 6, 9, and 12 Months
Percentage of Patients by Number of 177Lu-PSMA-617 Cycles		Up to approximately 10 years
Time to Next Treatment (TTNT)	TTNT was defined as time from the start of 177Lu-PSMA-617 therapy to the initiation of a new LOT.	Up to approximately 10 years
Number of Patients With a Change in PSA Levels While on 177Lu-PSMA-617 by Percent Reduction in PSA	Reduction in PSA was categorized as ≥50%, ≥80%, and ≥90%.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Treatment response; Overall survival; Metastatic castrate-resistant prostate cancer; Treatment patterns
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CAAA617A1US19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO