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
Purpose
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.
Condition
- Prostatic Neoplasms, Castration-Resistant
Eligibility
- Eligible Ages
- Between 18 Years and 115 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Overall mCRPC Cohort | Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION. | |
| mCRPC Progression Subgroup | A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment. | |
| ≥1 Subsequent Systemic Therapy Subgroup | A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy. |
Recruiting Locations
Novartis
East Hanover, New Jersey 07936
East Hanover, New Jersey 07936
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals