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)

Bayer

Status: Begins enrollment this month

Conditions: Metastatic Hormone-Sensitive Prostate Cancer

Treatments: Drug: Darolutamide (BAY 1841788); Drug: ADT; Drug: Docetaxel

Study type: Observational

Funder types: Industry

Identifiers

NCT07344779

23100

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,600 participants in 2 patient groups

Darolutamide + ADT + Docetaxel (Triplet therapy)

Description:

This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with a combination of darolutamide, androgen deprivation therapy (ADT), and docetaxel. The decision to use this triplet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive all three treatments according to local standard of care.

Treatment:

Drug: Docetaxel

Drug: ADT

Drug: Darolutamide (BAY 1841788)

Darolutamide + ADT (Doublet therapy)

Description:

This group includes men with metastatic hormone-sensitive prostate cancer (mHSPC) who are treated with darolutamide and androgen deprivation therapy (ADT), but without docetaxel. The decision to use this doublet therapy is made by the treating physician as part of routine clinical practice before the patient enrolls in the study. Patients in this cohort receive darolutamide and ADT according to local standard of care.

Treatment:

Drug: ADT

Drug: Darolutamide (BAY 1841788)