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)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  PLUVICTO
• Study drug International non-proprietary name (INN) or common name:
  LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN
• Anatomical Therapeutic Chemical (ATC) code:
  (V10XX05) lutetium (177Lu) vipivotide tetraxetan

  lutetium (177Lu) vipivotide tetraxetan
• Medical condition to be studied:
  Prostate cancer metastatic

Population studied

• Short description of the study population:
  The study will include patients diagnosed with metastatic prostate cancer and who meet the following 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)
• Age groups:
  • Adult and elderly population (≥18 years)
• Estimated number of subjects:
  753

Study design details

• Study design:
  This study is planned as a non-interventional, longitudinal cohort study
• Main study objective:
  The primary objective of the study is to describe the real-world drug utilisation of lutetium (177Lu) vipivotide tetraxetan in patients diagnosed with metastatic prostate cancer;
• Setting:
  Clinical routine care treatment
• Outcomes:
  The proportion and number of patients who receive any given number of lutetium (177Lu) vipivotide tetraxetan cycles;
• Data analysis plan:
  This study is observational, and all data analyses will be descriptive in nature as there are no prespecified hypotheses. The primary analysis is the number and proportion of patients with any given number of lutetium (177Lu) vipivotide tetraxetan cycles (e.g., 1 cycle, two cycles, ... 6 cycles), described using counts and percentages.; Secondary analyses will be as follows:; • Patient profile (demographic and clinical characteristics), which will be reported as the number of non-missing observations, mean, SD, median, minimum, maximum, and IQR for continuous variables and counts and percentages for categorical variables.; • Survival outcomes (rwOS, median rwOS, five-year rwOS, rwPFS, median rwPFS, five-year rwPFS) will be assessed using time-to-event Kaplan-Meier methodology and will be reported as descriptive statistics (e.g., median time to event, IQR) with 95% CIs. Hazard ratio from Cox proportional hazards regression will be presented with 95% CIs. A p-value of less than 0.05 will be considered significant.; • Treatment response-related outcomes based on PSA level cutoffs will be reported as counts and percentages. Time to treatment response will be assessed using Kaplan-Meier methodology. Best overall response, overall response rate (complete response + partial response) and duration of response will be described.; • AESIs will be reported as counts and percentages.; • Changes in drug utilisation and treatment patterns will be described by reporting the number of non-missing observations, mean, SD, median, minimum, maximum, and IQR for continuous variables, and counts and percentages for categorical variables. TTNT,TTI, persistence and time to first change in dose or frequency of lutetium (177Lu) vipivotide tetraxetan outcomes will be analysed using Kaplan-Meier methodology and will be reported as descriptive statistics