Observational Study on Lutetium (177Lu) Vipivotide Tetraxetan to Treat Metastatic Castration Resistant Prostate Cancer

Novartis

Status: Enrolling

Conditions: Metastatic Castration Resistant Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07093801

CAAA617A1IT01

Details and patient eligibility

About

This is a local prospective, multicenter, long-term, non-interventional study using primary data collection to describe the routine clinical practice of patients with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan. The observation period will be from date of start of treatment up to a maximum of 18 months after end of treatment.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).
2. ≥ 18 years old at the time of enrollment.
3. Written informed consent must be obtained to participate to this study

In addition to the above-listed criteria, no other inclusion/exclusion criteria exist other than the requirements stated in the local Summary of Product Characteristics (SmPC) and in the "Scheda di Monitoraggio AIFA", e.g., contraindications.

Trial design

300 participants in 1 patient group

Patients diagnosed with mCRPC treated with lutetium (177Lu) vipivotide tetraxetan

Description:

Adult patients diagnosed with mCRPC eligible for and prescribed with lutetium (177Lu) vipivotide tetraxetan by the treating physician (Multidisciplinary Team).