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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07677267
Status
Recruiting
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Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - 115 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
1,067 participants (estimated)

Arms

  • Arm: 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.
  • Arm: mCRPC Progression Subgroup
    A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.
  • Arm: ≥1 Subsequent Systemic Therapy Subgroup
    A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.

Primary Outcome Measure

Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NovartisEast HanoverNew Jersey07936-

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Novartis· East Hanover, NJ

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