Last Update: Mar 05, 2026
Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan Injection in Metastatic Prostate Cancer: an Observational, Multicenter, Prospective Cohort Study in China (PSMAreal CN)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAAA617A1CN01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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

Metastatic Prostate Cancer
Recruiting
170
Feb 04, 2026
Aug 31, 2029
Male
18 Years - 99 Years (Adult, Older Adult)

Eligibility Criteria

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

Novartis Investigative Site

Recruiting

Shanghai,Shanghai Municipality,201321,China

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