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Completed

NCT Number: NCT07477756

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. Mean PSA Level

    Time frame: Baseline

  3. Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation

    Time frame: Baseline

  4. Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation

    Time frame: Up to approximately 2 years

  5. Duration of 177Lu-PSMA-617 Treatment

    Time frame: Up to approximately 2 years

  6. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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