Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

• Status: Completed
• Trial end date: 2021-06-14
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Orion Corporation, Orion Pharma

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.