A non-interventional, real-world study of HRRm testing, treatment patterns, and overall survival among patients with metastatic castration-resistant prostate cancer initiating treatment with talazoparib plus enzaluatime in the US.

Study type

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

  Effectiveness 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:
  TALZENNA

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

  ENZALUTAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L02BB04) enzalutamide

  enzalutamide

Population studied

• Short description of the study population:
  Study period: January 1, 2013, August 31, 2025 (or most recent available data).; Diagnosis date: date of first diagnosis record for mCRPC.; Treatment identification period: June 20, 2023, February 28, 2025.; Index date: defined as the first initiation date of the line of therapy (LOT) containing talazoparib plus enzalutamide. ; Baseline period: defined as any time prior to the index date during the study period. ; Follow-up period: defined as the time from index date (inclusive) until the earliest of death, administrative end date, or loss to follow-up. ; The following selection criteria have been applied by the data provider, Flatiron Health in order to define the patients included in the mCRPC spotlight data delivery: ; Inclusion criteria:; Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:; Included in Flatiron’s Health Research Database; Has two or more visits on distinct dates in Flatiron’s network; Has evidence of diagnosis of metastatic prostate cancer on or after January 1, 2013, as identified by a natural language processing (NLP)-based machine-learning (ML) model; Has evidence of treatment with enzalutamide and talazoparib on or after January 1, 2023, as identified by an NLP-based ML model or structured medication administrations or non-cancelled orders; Has evidence of mCRPC on or after January 1, 2013, as confirmed via unstructured documentation; Has histology of adenocarcinoma or not otherwise specified (NOS), as confirmed via unstructured documentation ; Has evidence of treatment with talazoparib in combination with enzalutamide on or after January 1, 2023, as defined per Flatiron’s LOT business rules; Exclusion criteria:; Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team; Birth sex is female or unknown; Additional study-specific eligibility criteria:; Inclusion criteria: ; ≥18 years of age on metastatic prostate cancer (mPC) diagnosis date; Has evidence of treatment with talazoparib in combination with enzalutamide on or after June 20, 2023 (ie, the approval date for enzalutamide and talazoparib in HRRm for mCRPC); 2.Exclusion criteria: ; Evidence of enrollment in a clinical trial during study period; Evidence of enzalutamide and talazoparib initiation prior to the mCRPC diagnosis date (ie, off-label use); Patients who discontinued treatment with talazoparib plus enzalutamide in less than 7 days of any initiation (ie, <7 days from the treatment initiation date to the discontinuation date) during the study period will be excluded. Reasons for discontinuation will be reported; Patients with other secondary malignancies or benign neoplasm during the study period
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Oncology patients, specifically with metastatic castration-resistant prostate cancer
• Estimated number of subjects:
  253

Study design details

• Study design:
  Non-interventional, retrospective cohort study of US patients with mCRPC treated with talazoparib plus enzalutamide, using Flatiron Health’s longitudinal, demographically and geographically diverse EHR-derived database to identify treatments between 20Jun2023 and 28Feb2025.
• Main study objective:
  What are the treatment patterns and characteristics of mCRPC patients initiating treatment with talazoparib plus enzalutamide combination in the real world?; Among patients with mCRPC initiating talazoparib plus enzalutamide combination therapy in the US:; To describe patient demographics and clinical characteristics including HRR testing and mutation status ; To assess treatment patterns in the metastatic setting including prior treatments, rwToT, reason for dose discontinuation, and dosing patterns; To describe rwTTNT, rwTTD, and rwOS
• Setting:
  Patients treated with talazoparib plus enzalutamide with HRRm mCRPC on or after 01Jan2023
• Comparators:
  No comparator
• Outcomes:
  Treatment pattern, dosing pattern, rw survival outcomes
• Data analysis plan:
  Analyses will be conducted using the Flatiron Health mCRPC Spotlight dataset. Data preparation will include assessments of duplicate records, variable formats, missingness, allowable ranges, implausible values, temporal sequencing, and logical consistency across related variables. Identified inconsistencies or errors will be addressed using prespecified programming rules documented in the protocol or programming specifications.; ; Study variables, including the index date, baseline and follow-up periods, HRRm testing variables, treatment regimens, lines of therapy, exposures, covariates, and clinical outcomes, will be derived using protocol-specified algorithms. No missing data will be imputed. The number and percentage of missing observations will be reported for relevant variables, and analysis denominators will be clearly identified.