NCT07450157Completed
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6448 (actual)
- First submitted
- 27 Feb 2026
- Start date
- 23 Jun 2023
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Prostate cancer
- NCT number
- NCT07450157
What you commit to
- Study type: Observational
- Participants enrolled: 6448
- From 23 Jun 2023 to the primary completion date, 28 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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.
Criteria the registry did not label
- Phase I inclusion criteria:
- 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.
- 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.
- At least 18 years of age at index date.
- Patients with ≥2 medical claims ≥180 days prior to the index date.
- For the treatment response analysis, the following additional criteria were applied:
- Patients with linkage to lab data.
- 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 PSA result available after the index date.
- Phase II inclusion criteria:
- ≥2 medical claims (≥30 days apart) with a diagnosis of prostate cancer observed during the patient selection period.
- ≥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.
- 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.
- ≥12 months of continuous data availability prior to the mCRPC diagnosis date.
- ≥1 claim for 177Lu-PSMA-617 after mCRPC diagnosis and continuous data availability between diagnosis and the date of 177Lu-PSMA-617 initiation.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.