A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients

Real-World Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients Receiving Lutetium-177 Vipivotide Tetraxetan

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07477756

Enrollment

1247

Registered

2026-03-17

Start date

2024-09-04

Completion date

2025-03-14

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Lutetium-177 (177Lu) Vipivotide Tetraxetan, 177Lu-PSMA-617, Clinical Outcomes, Prostate Cancer, Prostate-specific Antigen, Metastatic Castration-resistant Prostate Cancer

Brief summary

The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Evidence of 177Lu-PSMA-617 use on or after March 23, 2022 * Date of initiation of 177Lu-PSMA-617 available in the data * Age ≥18 years at index

Exclusion criteria

• None

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients by Patient Characteristic	Baseline	Patient characteristics included: * Age * Race * Marital status * Insurance status * Practice type * Physician specialty * Geographic region * Have a Gleason score ≤1 year of index * Gleason score (\<7, ≥7) * Have a prostate-specific antigen (PSA) test ≤1 year of index * PSA level (elevated, normal, unknown)
Mean PSA Level	Baseline	—
Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation	Baseline	—
Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation	Up to approximately 2 years	—
Duration of 177Lu-PSMA-617 Treatment	Up to approximately 2 years	—
Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation	Up to approximately 2 years	—

Secondary

Measure	Time frame	Description
Number and Percentage of Patients With a Reduction in PSA Level	Baseline up to approximately 2 years	Reduction in PSA level was categorized as follows: * ≥50% (PSA50) reduction in PSA level * ≥80% (PSA80) reduction in PSA level * ≥90% (PSA90) reduction in PSA level

Countries

United States

Contacts

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results