Open-label study of Androgen Receptor Inhibition with dArolutamide plus Androgen Deprivation Therapy (ADT) Versus ADT in men with Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm (ARASEC)

Investigator: Eleni Efstathiou, MD

Study Coordinator: Gabrielle Hayes

Status: Open Not Enrolling

ClinicalTrials.gov Number: NCT05059236

Phone: 734.419.948

Protocol Number: PRO00036218

Description

This is a phase 2 open label single arm study using an external control arm, to assess if the addition of darolutamide to ADT provides superior efficacy in terms of progression-free survival (PFS), as compared to ADT alone for men diagnosed with metastatic hormonesensitive prostate cancer (mHSPC). The primary endpoint is progression-free survival (PFS), Approximately 200 mHSPC participants will receive darolutamide plus ADT in the ARASEC active treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach.The study will comprise the following consecutive periods: Screening, Treatment period, Active Follow–up period and Survival Follow–up period
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