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Recruiting NCT07290270

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

Trial Parameters

Condition Metastatic Prostate Cancer
Sponsor Novartis Pharmaceuticals
Study Type OBSERVATIONAL
Phase N/A
Enrollment 170
Sex MALE
Min Age 18 Years
Max Age 99 Years
Start Date 2026-02-04
Completion 2029-08-31

Brief Summary

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.

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

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