Phase 3
N=669
Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Prostatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT04736199 ↗Enrolled (actual)
669
Serious AEs
23.6%
Results posted
Aug 2025
Primary outcome: Primary: Radiological Progression-free Survival (rPFS) Assessed by Central Review — NA; 25.0 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darolutamide (Nubeqa, BAY1841788) (Drug); Placebo (Drug); Androgen deprivation therapy (ADT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bayer
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological Progression-free Survival (rPFS) Assessed by Central Review |
NA; 25.0 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.1007 |
| SECONDARY Time to Castration-Resistant Prostate Cancer (CRPC) |
NA; 13.8 | — |
| SECONDARY Time to Initiation of Subsequent Anti-cancer Therapy |
NA; NA | — |
| SECONDARY Time to PSA Progression |
NA; 16.8 | — |
| SECONDARY PSA Undetectable Rates (<0.2 ng/mL) |
62.6; 18.5 | — |
| SECONDARY Time to Pain Progression |
NA; 29.9 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety |
405; 199; 105; 52; 144; 64 | — |
Summary
The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease
- Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
- Adequate bone marrow, liver and renal function
Exclusion Criteria
- Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
- Treatment with radiotherapy within 2 weeks before randomization
- Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
- Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
- Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
- A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
- Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
- Inability to swallow oral medications
Data sourced from ClinicalTrials.gov (NCT04736199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.