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Recruiting NCT07677267

A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

— Observational Prostatic Neoplasms, Castration-Resistant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms, Castration-Resistant. Basic parameters: 18 years — 115 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

Overview

The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.

Primary outcome measures

  • Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date [Time frame: Baseline]
  • Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) [Time frame: Baseline]
  • Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans [Time frame: Baseline up to approximately 5 years]
  • Number of Patients by Timing of PSMA Scans [Time frame: Baseline up to approximately 5 years]
  • Number of Patients by Number of Post-index LOTs [Time frame: Up to approximately 5 years]
  • Number of Patients by Type of Therapy at Each Post-index LOT [Time frame: Up to approximately 5 years]
  • Time From Index Date to Next Therapy Initiation [Time frame: Up to approximately 5 years]
Secondary outcome measures (8)
  • Number of Patients by Patient Characteristics [Time frame: Baseline]
  • Age [Time frame: Baseline]
  • Progression-free Survival (PFS) From Index Date [Time frame: Up to approximately 5 years]
  • PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy [Time frame: Up to approximately 5 years]
  • Overall Survival (OS) From Index Date [Time frame: Up to approximately 5 years]
  • OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy [Time frame: Up to approximately 5 years]
  • Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level [Time frame: Up to approximately 5 years]
  • Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy [Time frame: Up to approximately 5 years]

Eligibility criteria

Inclusion criteria

  • Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
  • Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
  • Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
  • Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
  • Age ≥18 years at index.

Exclusion criteria

  • None.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Novartis — East Hanover

Identifiers

NCT: NCT07677267 · CAAA617A1US30

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗