Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Starting soon
Conditions studied: Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
In brief
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.
Key facts
- Study ID
- NCT07697989
- Run by
- Novartis Pharmaceuticals
- People needed
- 1085
- Starts
- 2026-10-15
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
- 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.
- Patients ≥18 years of age on metastatic diagnosis date.
- Patients who are male.
- 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).
You may not qualify if…
- 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.
- 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).
- Patients with missing age and gender information.
Full record on ClinicalTrials.gov
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