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Recruiting Observational

Pluvicto Real-world Investigation in Survival in Metastatic CRPC

NCT07697989 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-10-01
Last updated
2026-10-30

Condition(s) studied

Prostatic Neoplasms, Castration-ResistantNeoplasm Metastasis

Study summary

This study aims to evaluate the various aspects of treatment effectiveness of \[177Lu\]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date. 2. Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date. 3. Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria. 4. Patients with evidence of treatment with \[177Lu\]Lu-PSMA-617 after the mCRPC diagnosis date. The date of \[177Lu\]Lu-PSMA-617 administration will be considered as the index date. 5. Patients ≥18 years of age on metastatic diagnosis date. 6. Patients who are male. 7. Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap). Exclusion criteria: 1. Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis. 2. Patients enrolled in a current clinical trial/investigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6). 3. Patients with missing age and gender information.

Primary outcome measure(s)

  • Real-World Overall Survival (rwOS) — Up to approximately 3 years
    rwOS, defined as the time from index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, until death due to any cause.
  • Median rwOS — Up to approximately 3 years
    Median rwOS, defined as the time from the index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.

Trial sites (1)

FacilityCityRegionStatus
Novartis East Hanover New Jersey Recruiting
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 NCT07697989 on ClinicalTrials.gov ↗ ← All trials in the USA