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

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

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 proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participation in an investigational program with interventions outside of routine clinical practice
• Contraindications according to local marketing authorization
• Any prior treatment with second-generation AR inhibitors (enzalutamide, apalutamide, or investigational AR inhibitors), CYP17 inhibitors (abiraterone acetate or investigational CYP17 inhibitors) as antineoplastic treatment for prostate cancer
• Prior hormone therapy in the metastatic setting
• Treatment with darolutamide initiated more than 7 days prior to enrollment