Clinical Trials in the USA / NCT07677267
Recruiting
Observational
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
NCT07677267 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Prostatic Neoplasms, Castration-Resistant
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date — Baseline
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. - Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) — Baseline
Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC. - Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans — Baseline up to approximately 5 years
- Number of Patients by Timing of PSMA Scans — Baseline up to approximately 5 years
Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. - Number of Patients by Number of Post-index LOTs — Up to approximately 5 years
- Number of Patients by Type of Therapy at Each Post-index LOT — Up to approximately 5 years
- Time From Index Date to Next Therapy Initiation — Up to approximately 5 years
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis | East Hanover | New Jersey | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07677267 on ClinicalTrials.gov ↗ ← All trials in the USA