COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

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.