Clinical trial NCT02200614 (phase 3, status: active, not recruiting)
Conditions: prostate cancer non-metastatic, castration-resistant
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: darolutamide (nubeqa, bay1841788), placebo
SMILES: C[C@@H](CN1C=CC(=N1)C1=CC=C(C#N)C(Cl)=C1)NC(=O)C1=NNC(=C1)C(C)O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.