Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.
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
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.
Adult men with de novo metastatic hormone-sensitive prostate cancer initiating androgen receptor pathway inhibitor therapy in US community urology clinics
Cohort
Retrospective
Darolutamide
DrugAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Abiraterone acetate
DrugAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Enzalutamide
DrugAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
Apalutamide
DrugAndrogen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
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Treatment groupsSee each treatment group below.
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age
Age will be documented in years to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age
Age will be documented in years to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication
Number of concomitant medication will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT + docetaxel in adult men diagnosed with de novo mHSPC in US urology clinics.
Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication
Number of concomitant medication will be recorded to characterize the real-world utilization and treatment outcomes for the darolutamide combination with ADT in adult men diagnosed with de novo mHSPC in US urology clinics.
