A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of prostate. Participantsmay have begun androgen-deprivation therapy (up to 120 days prior to enrollment).Note: Relugolix is not permitted as ADT in this study.

• Metastatic disease and will be stratified by presence of high volume or low volumedisease.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2

• Adequate bone marrow, liver and renal function within 4 weeks of enrollment

• At least 4 weeks since prior major surgery and recovered from all toxicity from suchsurgery prior to enrollment

• Prior adjuvant or neoadjuvant hormonal therapy allowed provided the followingcriteria are met:

• Therapy was discontinued ≥ 12 months ago AND there was a clinical state withoutevidence of disease at least 12 months after completing adjuvant or neoadjuvanthormonal therapy, as defined by 1 of the following:

• PSA < 0.1 ng/mL after prostatectomy plus hormonal therapy

• PSA < 0.5 ng/mL and has not doubled above nadir after radiotherapy plushormonal therapy

• Therapy lasted no more than 24 months

• Prior palliative radiotherapy allowed for participants, if commenced within 30 daysbefore starting androgen deprivation.

• Bicalutamide, nilutamide or flutamide are allowed as single-agent therapy ≤ 28 daysbefore medical castration to prevent flare.

Exclusion Criteria:

• PSA met criteria for PSA progression

• History of malignancy in the past 5 years, with the exception of basal cell andsquamous cell carcinoma of the skin.

• Had any of the following within 6 months before randomization: myocardialinfarction, severe/unstable angina pectoris, congestive heart failure,hospitalization for any cardiac event, including conduction abnormalities

• Pathological finding consistent with small cell, or neuroendocrine carcinoma of theprostate

• Known brain/ leptomeningeal metastases

• An active viral hepatitis (defined as Hepatitis B surface antigen [HBsAg] reactiveor detectable [qualitative] HBV DNA defined as HCV Ribonucleic Acid [RNA] [qualitative] is detected), known human immunodeficiency virus infection withdetectable viral load, or chronic liver disease with a need of treatment

• Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg ordiastolic BP ≥ 100 mmHg despite medical management

• A gastrointestinal (GI) disorder or procedure which is expected to interferesignificantly with absorption of study drug

• Any other serious or unstable illness, or medical, social, or psychologicalcondition, that could jeopardize the safety of the participant and/or his compliancewith study procedures or may interfere with the participant's participation in thestudy or evaluation of the study results.

• Prior hormone therapy in the metastatic setting

• Prior chemotherapy in the adjuvant or neoadjuvant setting

• Concurrent use or previous exposure of 5-alpha reductase inhibitors (within 28 daysbefore the start of darolutamide or 5 half-lives of the drug, whichever is longer)

• Any Prior treatment with second-generation androgen receptor (AR) inhibitors such asenzalutamide, apalutamide, darolutamide, or other investigational AR inhibitors,Cytochrome P17 enzyme inhibitor such as abiraterone acetate or other investigationalCYP 17 as antineoplastic treatment for prostate cancer

• Previous (within 28 days before the start of darolutamide or 5 half-lives of theinvestigational treatment of the previous study, whichever is longer) or concomitantparticipation in another clinical study with investigational medicinal product(s).

• Contraindication to both CT and MRI contrast agent

• Hypersensitivity to any of the study treatments, study treatment classes, orexcipients in the formulation of the study treatments

• Inability to swallow oral medications