• Age ≥18 years

• Histologically confirmed adenocarcinoma of the prostate

• High-risk and/or locally advanced prostate cancer diagnosis defined by:

• One of the following criteria is sufficient to define a high-risk and/or locally advanced prostate cancer:

⁃ ISUP grade 4 or 5 on biopsies

⁃ cN1 disease in MRI or PET-Scan

⁃ T3b disease in MRI

• If these criteria are not being identified, two of the following criteria are necessary to define high-risk and/or locally advanced prostate cancer:

⁃ PSA value \>20 ng/ml

⁃ ≥ 50% of the core of biopsies need to be positive for adenocarcinoma ISUP grade 3

⁃ T3a disease in MRI

• No distant metastasis confirmed by imaging (i.e., MRI/CT-Scan and Bone Scintigraphy or PET-Scan)

• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1

• Patient eligible for radical prostatectomy as per the investigator

• Adequate organ function within 28 days prior to start of treatment determined by the following central laboratory values:

‣ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin less than the upper limit of normal (ULN; note that in subjects with Gilbert's syndrome, if total bilirubin is \>1.5 X ULN, measure direct and indirect bilirubin. If direct bilirubin is ≤1.5 X ULN, the subject may be eligible);

⁃ Serum creatinine \<1.5 mg/dL;

⁃ Platelets ≥75,000/uL, without transfusion and/or growth factors within 1 month prior to randomization;

⁃ Hemoglobin \>12.0 g/dL (7.4 mmol), without transfusion and/or growth factors within 1 month prior to randomization;

⁃ Adequate renal function: creatinine clearance/eGFR within normal limits to baseline assessed as per local standard method;

⁃ Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording).

• Patient able to receive darolutamide for up to 9 months as per the investigator

• Patient able to swallow whole study drug tablets

⁃ Life expectancy more than 5 years

⁃ Men engaged in sexual activity with a woman of childbearing potential should accept (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) to use an highly effective contraception during darolutamide treatment and at least one week after the end of the investigational product

⁃ Signed informed consent

⁃ Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations including follow up

⁃ Patient affiliated to a Social Health Insurance in France.