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Pluvicto Real-world Investigation in Survival in Metastatic CRPC

Not Yet RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.