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Recruiting NCT07290270

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

— Observational Metastatic Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metastatic Prostate Cancer. Basic parameters: 18 years — 99 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan Injection in Metastatic Prostate Cancer: an Observational, Multicenter, Prospective Cohort Study in China (PSMAreal CN)

Overview

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.

Detailed 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

Primary outcome measures

  • 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]
  • prostate-specific antigen (PSA) 90 response rate [Time frame: from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit]
Secondary outcome measures (12)
  • Progression-Free Survival (PFS) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Radiographic progression-free survival (rPFS) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Clinical PFS [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Time to PSA progression [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Second Progression-Free Survival (PFS2) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • OS [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Time to a first symptomatic skeletal event (SSE) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Time to first subsequent therapy [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Disease control rate (DCR) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Objective response rate (ORR) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Time to response (TTR) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]
  • Duration of response (DoR) [Time frame: Data collection for radiographic assessment outcomes: from 3 months before the index date to 1 year after the EOT visit / Data collection for non-radiographic assessment outcomes: from 1 month before the index date to 1 year after the EOT visit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Novartis Investigative Site — Shanghai

Identifiers

NCT: NCT07290270 · CAAA617A1CN01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗