An International, Multicenter, Prospective Non-Interventional Study of Real-World Treatment Outcomes in Patients with Metastatic Castrate Resistant Prostate Cancer (mCRPC) treated with Talazoparib and Enzalutamide (TALENZA)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TALZENNA

  XTANDI
• Study drug International non-proprietary name (INN) or common name:
  ENZALUTAMIDE

  TALAZOPARIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XK04) talazoparib

  talazoparib

  (L02BB04) enzalutamide

  enzalutamide
• Medical condition to be studied:
  Hormone-refractory prostate cancer

Population studied

• 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)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  To characterize the effectiveness and safety profile of talezoparib and enzalutamide To describe supportive care measures, healthcare utilization, and physician management in relation to safety outcomes To evaluate quality-of-life (QoL) To capture the next anti-cancer treatment after discontinuation of talazoparib and enzalutamide
• Outcomes:
  Outcomes of interest: Effectiveness: real-world progression free survival (rwPFS), second real-world progression-free survival (rwPFS-2), real-world overall survival (rwOS), PSA response, PSA doubling time, real-world objective response rate (rwRR), and real-world time to next treatment (rwTTNT) Safety: safety events of interest Healthcare resource use
• Data analysis plan:
  The characteristics captured during baseline assessment and follow up will be summarized using descriptive statistics. To evaluate the safety of talazoparib and enzalutamide, AEs and SAEs will be characterized by type, grade, timing, and seriousness. Cumulative incidence will be calculated as appropriate and will be further described in the SAP. For the effectiveness outcomes of interest, rwPFS2, rwPFS, and rwOS (time to event outcomes) will be evaluated using Kaplan-Meier (KM) methods. KM curves will be illustrated and the median survival and corresponding 95% confidence interval (95% CI) will be computed. Subgroup analyses may be conducted by HRRm status, prior treatment lines (NHTs, taxane, etc.), age, race/ethnicity, year of enrollment, enrollment country, and other key subgroups pending sufficient sample size.