PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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: No limits · 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
- Center list to be confirmed — check the primary protocol.
- 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
Understanding Drug Utilisation, Treatment Patterns, Clinical Outcomes, and Profile of the Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan for the Treatment of Metastatic Prostate Cancer: a Multicountry, AI-powered Registry (PULSE)
Overview
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer
Detailed description
This study is planned as a multicountry, non-interventional, longitudinal AI-enhanced digital registry that will leverage advanced data extraction technologies to efficiently generate RWD.
The primary objective of the study is to describe real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan among patients with metastatic prostate cancer.
Primary outcome measures
- Proportion and number of patients who receive any given number of lutetium (177Lu) vipivotide tetraxetan cycles [Time frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years]
Secondary outcome measures (12)
- Patient demographics [Time frame: Baseline]
- Number of participants by clinical characteristics [Time frame: Baseline]
- real-world overall survival (rwOS) [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- median rwOS [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- Five-year rwOS [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- Real-world progression-free survival (rwPFS) [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- Median rwPFS [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- Five-year rwPFS [Time frame: Date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the earliest of end of follow-up or last available EHR record, or the event date, up to 5 years]
- PSA 30 response rate [Time frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years]
- PSA 50 response rate [Time frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years]
- PSA 90 response rate [Time frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years]
- Time to treatment response [Time frame: From the date of the first administration of lutetium (177Lu) vipivotide tetraxetan (index date) until the end of follow-up, up to 5 years]
Eligibility criteria
Inclusion criteria
Age ≥ 18 years at index date
- Diagnosis of mPC
- PSMA positive
- Received at least one dose of lutetium (177Lu) vipivotide tetraxetan on or after mPC diagnosis date
Exclusion criterion:
- Current or prior participation in an investigational study within the 30-day period immediately prior to and including the index date, or within five half-lives of the investigational product (whichever is longer)
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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07484269 · CAAA617A02001