Observational prospective study describing the global patient care and follow-up of prostate cancer patients treated with Degarelix (DUO study (Dialogue in Uro-Oncology))

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-authorization safety study (PASS)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L02BX02) degarelix

  degarelix

Population studied

• Short description of the study population:
  Inclusion criteria; Only patients who meet all the following inclusion criteria will be considered for inclusion in the study:; • Male aged 18 years or older; • Diagnosed with hormone dependant advanced prostate cancer PCa; • Patient having received an antagonist of GnRH Degarelix prescription; • Agreeing to and capable of completing in French during the visits all questionnaires on the impact of their illness and treatment; • Patients having received oral and written study information, agreeing to the use of his anonymized data, and having signed a written Informed Consent Form.; Exclusion criteria; Patients will not be included in the study if they meet at least one of the following exclusion criteria:; • Patient included in an interventional study assessing treatment for PCa,; • Patient presenting hypersensitivity to Degarelix or one of its excipients,; • Patient treated by other hormonotherapy
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Prostate cancer patients
• Estimated number of subjects:
  170

Study design details

• Main study objective:
  To describe the prevalence of the cardiovascular comorbidities, at the initiation of Degarelix, in prostate cancer patients.
• Outcomes:
  A patient will be considered to have cardiovascular comorbidities if he has a history of at least one cardiovascular illness and/or at least three cardiovascular risk factors. - To describe the real life prevalence of comorbidities: Metabolic, osteoporotic, for elderly patients, and for mood and sexual disorders - To describe the modification of the comorbidities after 6 months (cardiac, metabolic, osteoporotic, geriatric, mood and sexual disorders) - To describe the Quality of Life for prostate cancer patients - To evaluate tolerance (adverse events)
• Data analysis plan:
  The prevalence of cardiovascular comorbidities will be described along with the 95% CI. Note: The method of physician selection will not ensure sample representativeness, and furthermore physicians can refuse to participate in the study. Sample representativeness will thus be determined by comparing the initial sample of the Sponsor’s national database of sites with the sample of active sites. All results should be interpreted cautiously. In addition, as part of an observational study with prospective cohort study evaluated over a 6-months period, it is important to take into account the handling of missing data for the primary endpoint when considering the accuracy of estimation and relevance of the study results. Nonetheless, because the primary objective is evaluated at baseline, this bias should be reduced