Pluvicto real-world use in metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes real-world data to describe treatment effectiveness of [177Lu]Lu-PSMA-617 (Pluvicto) in patients with metastatic castration-resistant prostate cancer, in both pre- and post-taxane settings. It uses routine clinical and claims data from the United States and Germany to capture outcomes such as survival and other effectiveness measures. No interventional procedures are performed within the study framework; data are extracted from existing records. Eligible participants are adults with a confirmed metastatic prostate cancer diagnosis who received Pluvicto after mCRPC, with at least 12 months of prior data available for context. The study is sponsored by Novartis Pharmaceuticals and conducted at sites associated with the sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.