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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Darolutamide
  Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
• Препарат Abiraterone acetate
  Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
• Препарат Enzalutamide
  Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
• Препарат Apalutamide
  Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Первичные конечные точки

• Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age [Срок оценки: Baseline]
• Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication [Срок оценки: Baseline]
• Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): ethnicity [Срок оценки: Baseline]
• Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): ethnicity [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Charlson Comorbidity Index [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Charlson Comorbidity Index [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Gleason Score [Срок оценки: Baseline]
• Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Gleason Score [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company — Cleveland

Идентификаторы

NCT: NCT07406282 · 23094

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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