Phase 3
Completed N=1,509
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Prostate Cancer Non-Metastatic · Castration-Resistant
Source: ClinicalTrials.gov NCT02200614 ↗
Enrolled (actual)
1,509
Serious AEs
29.7%
Results posted
Oct 2019
Primary outcomePrimary: Metastasis-Free Survival — 40.37; 18.43 months — p=<0.000001
◆ Published Evidence
Emerging
16citations · ~5 / year
Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial.
Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Linked Publications (5)
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Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial.
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Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS.
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Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis.
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Lower Testosterone Level and Metastases-Free Survival in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Novel Antiandrogens: A Post Hoc Analysis of SPARTAN and ARAMIS.
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Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metastasis-Free Survival |
40.37; 18.43 | <0.000001 sig |
| SECONDARY Overall Survival - Primary Analysis |
NA; NA | 0.045210 sig |
| SECONDARY Time to Pain Progression - Primary Analysis |
40.31; 25.36 | 0.000008 sig |
| SECONDARY Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis |
NA; 38.21 | <0.000001 sig |
| SECONDARY Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis |
NA; NA | 0.011262 sig |
| SECONDARY Overall Survival - Final Analysis |
NA; NA | 0.003048 sig |
| SECONDARY Time to Pain Progression - Final Analysis |
40.31; 25.36 | 0.000008 sig |
| SECONDARY Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis |
NA; NA | 0.000044 sig |
| SECONDARY Time to First Symptomatic Skeletal Event (SSE) - Final Analysis |
NA; NA | 0.005294 sig |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
- Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA > 2ng/ml.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
Exclusion Criteria
- History of metastatic disease at any time or presence of detectable metastases.
- Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
- Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
- Prior chemotherapy or immunotherapy for prostate cancer.
- Use of systemic corticosteroid.
- Radiation therapy within 12 weeks before randomisation.
- Severe or uncontrolled concurrent disease, infection or co-morbidity.
- Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before randomisation.
- Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Uncontrolled hypertension.
- Prior malignancy.
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
- Treatment with any investigational drug within 28 days before randomisation.
- Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.
Data sourced from ClinicalTrials.gov (NCT02200614) 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.