Bayer’s ROAD Study Targets Real-World Upside for Nubeqa in Advanced Prostate Cancer

Bayer AG (BAYRY) announced an update on their ongoing clinical study.

Study Overview
The ROAD study (Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer) is an international observational study sponsored by Bayer to track how men with advanced, hormone-sensitive prostate cancer respond to darolutamide-based therapy in everyday practice. The main goal is to see how many patients reach very low prostate-specific antigen (PSA) levels after one year of treatment, while also capturing survival, treatment patterns, safety, and quality of life. The results should help clarify how darolutamide performs outside strict trial settings, which matters for doctors, payers, and investors watching the prostate cancer market.

Intervention/Treatment
The study follows patients treated with darolutamide (marketed as Nubeqa), an oral prostate cancer drug, given with standard hormone therapy, known as androgen deprivation therapy (ADT). Some patients will also receive docetaxel, a widely used chemotherapy. The purpose is not to test new drugs, but to compare outcomes between “doublet” treatment (darolutamide + ADT) and “triplet” treatment (darolutamide + ADT + docetaxel) as they are used in routine care.

Study Design
This is a non-interventional, observational cohort study, which means doctors choose the treatment upfront as part of normal care and then patients are simply followed over time. There is no random assignment, no placebo, and no blinding. Data are collected prospectively from electronic case report forms to describe what happens in two groups: those on doublet therapy and those on triplet therapy. The main purpose is to understand real-world effectiveness and safety, rather than prove cause-and-effect like a traditional randomized trial.

Study Timeline
The study is listed as “not yet recruiting” and was first submitted on December 15, 2025, indicating that sites are still preparing to enroll patients. The latest update on ClinicalTrials was submitted on January 23, 2026, confirming that the protocol and timelines have been recently reviewed. Primary completion and final completion dates have not yet been reported, but interim analyses are planned once 200, 400, and 600 patients per group complete at least 12 months of treatment or stop therapy, suggesting that early real-world signals could appear a few years after recruitment begins.

Market Implications
For Bayer (BAYRY), this study is a strategic move to strengthen the real-world evidence base for Nubeqa in metastatic hormone-sensitive prostate cancer, an area with strong competition from drugs such as enzalutamide (Pfizer/Astellas) and apalutamide (Johnson & Johnson). If the ROAD data show strong PSA responses, manageable side effects, and practical benefits of doublet or triplet therapy in routine care, this could support broader guideline uptake, better reimbursement, and stronger pricing power over time. That would be supportive for revenue visibility and may underpin sentiment for Bayer’s pharma segment, even as the group faces headwinds in other businesses. On the other hand, weaker-than-expected outcomes or safety concerns could dampen enthusiasm and shift share toward rival agents. Investors should view this update as an early sign that Bayer is investing in long-term data generation, with the main impact likely medium to long term rather than immediate. The observational design means the data will be more about confirming real-world value than creating binary, trial-style catalyst risk.

The ROAD study is active at the planning stage and recently updated, with further details and ongoing changes available on the ClinicalTrials portal.

To learn more about BAYRY’s potential, visit the Bayer AG drug pipeline page.