Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Trial Status: Complete
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.
- 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.
- 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.
University of California San Diego
Contact: Frederick Edward Millard
Rocky Mountain Regional VA Medical Center
Contact: Barbara Ciminelli
Indiana University / Melvin and Bren Simon Cancer Center
Massachusetts General Hospital Cancer Center
Dartmouth Hitchcock Medical Center
Contact: Sergey Devitskiy
Montefiore Medical Center-Weiler Hospital
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Case Comprehensive Cancer Center
University of Oklahoma Health Sciences Center
Trial Phase Phase III
Trial Type Treatment
- Primary ID 17712
- Secondary IDs NCI-2015-00347, 2013-003820-36, s14-00582
- Clinicaltrials.gov ID NCT02200614