Informations générales (source: ClinicalTrials.gov)
ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Observational
Bayer (Voir sur ClinicalTrials)
janvier 2026
juin 2030
14 septembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Yann NEUZILLET | 21/09/2026 17:46:47 | Contacter | ||
Critères
Homme
- 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