Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)

Novartis

Status: Not yet enrolling

Conditions: Metastatic Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07290270

CAAA617A1CN01

Details and patient eligibility

About

This non-interventional, observational, multicenter, prospective cohort study is designed to investigate the treatment patterns of mPC patients treated with lutetium (177Lu) vipivotide tetraxetan, as well as their clinical outcomes, real-world characteristics, and quality of life during the treatment period and up to one year after treatment completion.

Full description

The study population will be divided into two cohorts, enrolling patients with mCRPC and mHSPC, respectively. Patients planned to receive lutetium (177Lu) vipivotide tetraxetan treatment according to treating physician's assessment will be enrolled in the study upon signing an informed consent form. Patients must meet all inclusion criteria defined in the protocol and not meet any exclusion criteria. The patients' medical history, prostate cancer disease characteristics, demographics, and baseline data will be collected through medical records and examination reports. Treatment patterns, treatment outcomes, and HRQoL data will be collected during study follow-up visits through patient records, examination reports, and self-reported data. This study does not have a control group; instead, a self-control method will be used, with the patients' baseline data before the start of treatment serving as the control for efficacy, safety, and HRQoL assessments. The index date for this study is defined as the date of the first administration of lutetium (177Lu) vipivotide tetraxetan

Enrollment: 170 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult male patients diagnosed with mCRPC or mHSPC Initiating lutetium (177Lu) vipivotide tetraxetan treatment by treating physician as per local label. After treatment decision enrollment is allowed before date of cycle 1 or within 2 weeks after the date of cycle 1 Written ICF must be obtained prior to any data collection Participants must have adequate organ function following Society of Nuclear Medicine and Molecular Imaging (SNMMI) consensus (Hope et al., 2023)

Exclusion criteria

Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with lutetium (177Lu) vipivotide tetraxetan during the study period

Other protocol-defined inclusion / exclusion criteria may apply

Trial design

170 participants in 2 patient groups

Cohort 1

Description:

Patients diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) previously treated with at least one ARPI with or without taxane regimens.

Cohort 2

Description:

Patients diagnosed with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).