Lutetium (177Lu) vipivotide tetraxetan treatment for men with metastatic prostate cancer in China

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 is a non-interventional, prospective, multicenter cohort study enrolling men with metastatic castration-resistant or hormone-sensitive prostate cancer who are planned to receive lutetium (177Lu) vipivotide tetraxetan per their treating physician. Patients will be enrolled around the time of their first treatment dose and followed during therapy and for up to one year after treatment completion. Data collected will include medical history, disease characteristics, treatment patterns, clinical outcomes, safety, and patient-reported health-related quality of life drawn from medical records and self-reports. There is no randomized control group; each patient’s baseline data before treatment will serve as the comparator for outcome and safety analyses.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Shanghai, Shanghai Municipality, China 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.