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

Study acronym: ROAD
StatusRecruiting
PhaseNot specified
SponsorBayer
Started

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Record History

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  1. Notable Enrollment reopened Show 4 more changesShow less
    • Primary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 24 of 64 entries
    • Site details revised at 16 of 16 sites
  2. Notable Primary completion pushed from Dec 31, 2027 to Dec 31, 2029v4
  3. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Start date changed from estimate of Feb 17, 2026 to Jan 29, 2026
    v3
  4. Minor Study sites: 1 to 16
    • Start date: Jan 20, 2026 to Feb 17, 2026
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
131 trials monitored
See 11 trials at risk
2,550 trials monitored
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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 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.
Trial Details
NCT Number NCT07344779
Lead Sponsor Bayer
Conditions
(from sponsor)
Metastatic Hormone-Sensitive Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 1,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov