ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

Inclusion Criteria: * Histologically confirmed prostate cancer (all stages) for whom continuous androgen-deprivation therapy (ADT) is indicated for a minimum period of 24 weeks * Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone, extra-pelvic lymph nodes, and pelvic lymph nodes \> 2 cm on baseline Computed tomography(CT) or Magnetic resonance imaging (MRI) and/or Tc bone scintigraphy. Visceral metastases are excluded * Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed * Baseline testosterone ≥ 8 nmol/L or 230 ng/dL * Two subsequent PSA values ≥ 2 ng/ml, taken at minimum 2-week interval, with the second being equal to or higher than the first one * WHO performance status (PS) of 0-1 * G8 score ≥ 14 for patients aged ≥ 70 years old * A life expectancy of at least 12 months * Able to swallow the study drug and comply with the study requirements * Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 10exp9/L; hemoglobin ≥ 10.0 g/dl, platelets ≥ 100 10exp9/L) * Adequate renal function: creatinine clearance/eGFR within normal limits to baseline assessed as per local standard method * Albumin \> 25 g/L * Adequate hepatic function: Bilirubin: total bilirubin ≤ to 1.5 X upper limit of normal (ULN) * Aspartate aminotransferase (AST) and/or Alanine aminotransferase(ALT) ≤ 2.5 X ULN * Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording)…