A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics
Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA
Sponsor: Bayer
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Primary Endpoints (CT.gov)
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age
Time frame: Baseline
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age
Time frame: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication
Time frame: Baseline
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication
Time frame: Baseline
Eligibility Criteria
Inclusion Criteria: * Male patients with evidence of de novo mHSPC during the study period * Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis * Age ≥18 years at index date (ARPI initiation for mHSPC) * Initiation of ADT and/or docetaxel therapy within ±90 days from index date * At least 90 days of EMR activity prior to the index date * At least 90 days of EMR activity post-index, unless the patient died earlier. Exclusion Criteria: * History of other primary cancers (except non-melanoma skin cancer) * Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date * Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis * Clinical trial participation during the study period.
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