Clinical Research Directory

Inclusion Criteria: * Men ≥18 years of age; * Histologically confirmed unfavorable intermediate or high/very high risk non metastatic (by conventional imaging) prostate adenocarcinoma intended for surgery without neuroendocrine differentiation or small cell features; * Unfavorable intermediate-risk: * ISUP grade 3, and/or \> 50% positive biopsy cores and/or at least two intermediate-risk factors. Intermediate-risk factors: * Clinical tumor stage T2b or T2c (MRI based); * ISUP grade 2 or 3; * Prostate-specific antigen (PSA) level of 10-20 ng/mL. * High-risk or very high-risk: * ≥cT3a (MRI based) or ISUP 4-5 or PSA\>20 ng/mL; * cN1. * ECOG 0-1; * Baseline testosterone \> 230 ng/dL; * No prior prostate cancer treatment; * Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with darolutamide and for 1 week after the end of treatment with darolutamide to prevent pregnancy; * Written informed consent. Exclusion Criteria: * Unresectable prostate cancer; * Histology of small cell carcinoma prostate cancer or adenocarcinoma with neuroendocrine features; * Any prior prostate cancer treatment; * Any active infection requiring IV antibiotics; * Known additional malignancy that has a life-expectancy \< 2 years; * Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, heart failure with New York Heart Association Class Functional III or IV; * Uncontrolled severe hypertension as indicated by a resting systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg despite medical management; * A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of darolutamide; * Inability to swallow oral medications; * Receipt of medications (e.g. finasteride, dutasteride) or agents that are likely to alter serum PSA levels within \<= 42 days or 5 half-lives prior to registration, whichever is shorter.