Phase 3
Completed N=1,305
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer
Source: ClinicalTrials.gov NCT02799602 ↗
Enrolled (actual)
1,305
Serious AEs
44.7%
Results posted
Feb 2023
Primary outcomePrimary: OS From Date of Randomization Until Death From Any Cause - Number of Events — 229; 304; 422; 350 Participants — p=<0.0001
◆ Published Evidence
Highly cited
891citations · ~223 / year
Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.
Summary
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Linked Publications (3)
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Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.
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Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial.
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Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OS From Date of Randomization Until Death From Any Cause - Number of Events |
229; 304; 422; 350 | <0.0001 sig |
| PRIMARY OS From Date of Randomization Until Death From Any Cause - Month |
NA; 48.9 | — |
| SECONDARY Number of Participants With TEAEs |
649; 643; 306; 276; 172; 112 | — |
| SECONDARY Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events |
225; 391; 426; 263 | — |
| SECONDARY Time to Castration-Resistant Prostate Cancer (CRPC) - Month |
NA; 19.1 | <0.0001 sig |
| SECONDARY Time to Pain Progression - Number of Events |
222; 248; 429; 406 | — |
| SECONDARY Time to Pain Progression - Month |
NA; 27.5 | 0.0058 sig |
| SECONDARY Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events |
257; 329; 394; 325 | — |
| SECONDARY Symptomatic Skeletal Event Free Survival (SSE-FS) - Month |
51.2; 39.7 | <0.0001 sig |
| SECONDARY Time to First Symptomatic Skeletal Event (SSE) - Number of Events |
95; 108; 556; 546 | — |
| SECONDARY Time to First Symptomatic Skeletal Event (SSE) - Month |
NA; NA | 0.0081 sig |
| SECONDARY Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events |
219; 395; 432; 259 | — |
| SECONDARY Time to Initiation of Subsequent Antineoplastic Therapy - Month |
NA; 25.3 | <0.0001 sig |
| SECONDARY Time to Worsening of Disease-Related Physical Symptoms - Number of Events |
351; 308; 300; 346 | — |
| SECONDARY Time to Worsening of Disease-Related Physical Symptoms - Month |
19.3; 19.4 | 0.7073 |
| SECONDARY Time to Initiation of Opioid Use for ≥7 Consecutive Days - Number of Events |
92; 117; 559; 537 | — |
| SECONDARY Time to Initiation of Opioid Use for ≥7 Consecutive Days - Month |
NA; NA | 0.0037 sig |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Metastatic disease
- Candidates for ADT and docetaxel.
- Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria
- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
- 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)
- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease-free
- Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
- Inability to swallow oral medications
Data sourced from ClinicalTrials.gov (NCT02799602) and the linked publication. 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. Informational only — not medical advice.