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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07290270
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Dec 18, 2025
Start date
Feb 4, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
170 participants (estimated)

Arms

  • Arm: Cohort 1
    Patients diagnosed with Metastatic Castration-Resistant Prostate Cancer (mCRPC) previously treated with at least one ARPI with or without taxane regimens.
  • Arm: Cohort 2
    Patients diagnosed with Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Primary Outcome Measure

prostate-specific antigen (PSA) 50 response rate [ Time Frame: from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit ]

Central Contacts

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