Real-world Use of Lutetium (177Lu) Vipivotide Tetraxetan in China(PSMAreal CN)
ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will be recruited from approximately 25 research centers in China
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
170 Participants
are grouped into 2 trial groupsGroup A: Cohort 1
Group B: Cohort 2
Trial outcomes
Primary outcomes
1
prostate-specific antigen (PSA) 50 response rate
Defined as the proportion of patients with a confirmed decrease in PSA levels by ≥50% from baseline
Time frame
from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visit2
prostate-specific antigen (PSA) 90 response rate
Defined as the proportion of patients with confirmed decreases in PSA level by ≥90% from baseline
Time frame
from 1 month before the index date through to 1 year after the end-of-treatment (EOT) visitSecondary outcomes
1
Progression-Free Survival (PFS)
Defined as the time from the index date to the first occurrence of PSA progression or radiographic progression according to the Prostate Cancer Working Group 3 criteria, clinical progression assessed by the investigator, or death due to any cause (whichever occurs first)
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 visit2
Radiographic progression-free survival (rPFS)
Defined as the time from the index date to the first occurrence of radiographic progression according to the PCWG3 criteria or death due to any cause (whichever occurs first)
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 visit3
Clinical PFS
Defined as the time from the index date to the first occurrence of clinical progression assessed by the investigator or death due to any cause (whichever occurs first). Clinical progression is determined by the investigator and may be based on the following criteria: 1) Significant increase in tumor pain requiring initiation of another systemic anti-cancer treatment regimen; 2) The need to immediately start new anti-cancer treatment, surgery, or radiotherapy intervention due to complications caused by tumor progression, even in the absence of radiographic progression; 3) Deterioration of Eastern Cooperative Oncology Group (ECOG) performance status to ≥ 3, and the investigator determines that the deterioration indicates clinical 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 visit4
Time to PSA progression
Defined as the time from the index date to the first occurrence of PSA progression or death due to any cause. According to the PCWG3 criteria, PSA progression is defined as follows: 1. For patients whose PSA has declined from baseline: PSA increased by ≥25% compared with the lowest value and the absolute value was ≥2 ng/mL, and was re-evaluated and confirmed after ≥3 weeks. 2. For patients whose PSA has not declined from baseline: After at least 12 weeks of treatment with the study drug, the PSA level increased by ≥25% from the baseline and the absolute value was ≥2 ng/mL
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 visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov