- A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice — Recruiting • Oncology • NCT07344779.
- Sponsor: Bayer.
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This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the…
- : * Male patient with a diagnosis of mHSPC * Male aged ≥18 years (or country's legal age of adulthood if >18 years) * Histologically or cytologically confirmed adenocarcinoma of prostate; may have begun ADT (up to 120 days prior to enrollment) * Metastatic disease by conventional or new generation imaging * Decision to initiate treatment with darolutamide with or without docetaxel made prior to enrollment * Signed informed patient consent before start of data collection * Life expectancy of ≥3 months based on clinical judgment
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