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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

Recruitingn/aAges 18 Years - anyMaleBayer
NCT07406282 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 analyzi

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📋 Eligibility rules (as published)
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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What it tests

  • Darolutamide
  • Abiraterone acetate
  • Enzalutamide
  • Apalutamide
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Where

1 site
Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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