RENAISSANCE - A multi-centre, non-interventional study of RElugolix as aNdrogen-deprivAtion therapy In patientS with advanced hormone-Sensitive prostate cANCEr

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ORGOVYX
• Study drug International non-proprietary name (INN) or common name:
  RELUGOLIX
• Anatomical Therapeutic Chemical (ATC) code:
  (L02BX04) relugolix

  relugolix
• Medical condition to be studied:
  Prostate cancer

Population studied

• Age groups:
  Adult and elderly population (≥18 years)
• Estimated number of subjects:
  300

Study design details

• Study design:
  The goal of this study is to generate real word evidence from Europe about the population, effectiveness, and persistence of relugolix treatment in patients with advanced hormone-sensitive prostate cancer and their clinical; course during treatment.
• Main study objective:
  To describe the effectiveness of relugolix in patients with prostate cancer in a real-life setting.
• Setting:
  This European, multicentric, prospective cohort study (i.e. non-interventional) will be conducted in patients with advanced hormone-sensitive prostate cancer who are initiating treatment with relugolix with a planned duration of treatment of at least twelve months.
• Outcomes:
  - Demographics (country, age, ethnicity); - Baseline clinical characteristics (ECOG PS, baseline disease stage, location of metastases, baseline PSA level / testosterone, prior prostatectomy / radiotherapy / other local intervention, prior ADT, most recent ADT, concomitant medications for PCa, CV comorbidities/risks); - Medical history of prostate cancer (date of diagnosis, cTNM at diagnosis, Gleason, PSA, disease stage); - Relugolix data (date of initiation, reason, posology, interruption with the duration and the reason, date of discontinuation and reason); - Disease evolution during the follow-up (disease state, TNM, PSA, testosterone, interventions); - Concomitant medications for prostate cancer (name of the drug, date of initiation/discontinuation, posology, reason); - Safety (all AE, date, causality, severity)
• Data analysis plan:
  The primary goal of this study is to establish a database of clinical data from patients with prostate cancer treated with relugolix in a real-world practice setting that will characterize treatment patterns for prostate cancer and associated effectiveness and treatment persistence.; ; As such, no formal hypotheses will be tested in this study.