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

March 17, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients with evidence of treatment with 177Lu-PSMA-617.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Overall 177Lu-PSMA-617 Cohort
All patients treated with 177Lu-PSMA-617.
Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane
Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Prior Treatment Use Cohort: 1 ARPI and 1 Taxane
Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Prior Treatment Use Cohort: Delayed
Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.
Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment
Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone.
Subsequent Treatment Use Cohort: ARPI/Taxane
Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel).
Subsequent Treatment Use Cohort: ARPI
Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide).
Subsequent Treatment Use Cohort: Taxane
Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients by Patient Characteristic
Time Frame: 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)
Baseline
Mean PSA Level
Time Frame: Baseline
Baseline
Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation
Time Frame: Baseline
Baseline
Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Duration of 177Lu-PSMA-617 Treatment
Time Frame: Up to approximately 2 years
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
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Percentage of Patients With a Reduction in PSA Level
Time Frame: 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
Baseline up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAA617A1US13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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