A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Inclusion Criteria:

• Capable of giving signed informed consent.

• Participant must be male aged ≥ 18 years.

• Histologically or cytologically confirmed adenocarcinoma of prostate withoutneuroendocrine differentiation or small cell features.

• Castration resistance, demonstrated by:

• a minimum of 3 rising PSA values while the participant is on continuous ADT (started at least 4 weeks prior to the PSA measurement or, PSA measured atleast 4 weeks after bilateral orchiectomy) and

• the interval between each PSA measurement must be ≥ 1 week, and

• the PSA value at screening must be ≥ 1.0 ng/mL (1.0 μg/L). To confirm thiseligibility criterion, it is acceptable for 2 out of the 3 PSA measurements tobe taken during the 28-day screening period (after participant has signedconsent), provided the measurements are ≥ 1 week apart. In this case, the lastPSA value should be recorded as the screening value.

• Castrate level of serum testosterone (< 1.7 nmol/L [50 ng/dL]) on gonadotropinreleasing hormone (GnRH) agonist or antagonist therapy or after bilateralorchiectomy. Participants who have not undergone bilateral orchiectomy must continueGnRH therapy during the study.

• PSA doubling time (PSADT) of ≤ 10 months.

• Eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1.

• Estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m^2.

• Blood counts at screening: hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1500/μL (1.5 × 109/L), platelet count ≥ 100,000/μL (100 ×109/L) (participant mustnot have received any growth factor or blood transfusion within 7 days of thehematology laboratory obtained at screening).

• Screening values of serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of normal (ULN), total bilirubin (TBL) ≤ 1.5 × ULN (exceptparticipants with a diagnosis of Gilbert's disease), creatinine ≤ 2.0 × ULN.

• Sexually active participants, unless surgically sterile, must agree to use a malecondom plus partner use of a contraceptive method with a failure rate of <1% peryear, and refrain from sperm donation during the study treatment and for 1 weekafter the last dose of study treatment. Contraceptive use by men should beconsistent with local regulations regarding the methods of contraception for thoseparticipating in clinical studies.

Exclusion Criteria:

• History of metastatic disease at any time or presence of detectable metastases byinvestigator assessment within 42 days prior to start of study treatment based onstandard medical imaging, i.e., computed tomography/ magnetic resonance imaging (CT/MRI) and bone scan. (Lesions seen on prostate-specific membrane antigen /positron emission tomography (PSMA/PET) scan that are not detected on standardimaging do not exclude participation.) Presence of pelvic lymph nodes < 1.5 cm inshort axis below the aortic bifurcation is allowed.

• Symptomatic local-regional disease that requires medical intervention includingmoderate/severe urinary obstruction or hydronephrosis due to prostate cancer.

• Acute toxicities of prior treatments and procedures not resolved to commonterminology criteria for adverse events (CTCAE) v.5.0 grade ≤ 1 or baseline beforefirst dose of study treatment.

• Severe or uncontrolled concurrent disease, infection, or co-morbidity that, in theopinion of the investigator, would make the participant inappropriate forenrollment.

• Known hypersensitivity to the study treatment or any of its ingredients.

• Major surgery within 28 days before first dose of study treatment.

• Any of the following within 6 months before first dose of study treatment: stroke,myocardial infarction, severe/unstable angina pectoris, coronary/peripheral arterybypass graft; congestive heart failure New York Heart Association Class III or IV.

• Uncontrolled hypertension as indicated by a systolic blood pressure (BP) ≥ 160 mmHgor diastolic BP ≥ 100 mmHg at screening despite medical management. Participantswith hypertension can enroll provided BP is stable and controlled byanti-hypertensive treatment.

• End-stage renal disease (eGFR < 15 mL/min/1.73 m^2).

• Prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skinor superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for whichtreatment has been completed ≥ 5 years ago and from which the participant has beendisease-free.

• Gastrointestinal disorder or procedure which expects to interfere significantly withabsorption of study treatment.

• Unstable active viral hepatitis with a need for treatment.

• Known human immunodeficiency virus (HIV) infection with any of the following (Note:HIV testing is not required unless mandated by local authority):

• CD4+ T-cell (CD4+) count of less than 350 cells/μL

• History of acquired immunodeficiency syndrome (AIDS)-defining opportunisticinfection within the past 12 months

• On established antiretroviral therapy for less than 4 weeks

• Presenting with a viral load of more than 400 copies/mL prior to enrollment

• On antiretroviral therapy or prophylactic antimicrobials that are expected tocause significant drug-drug interactions or overlapping toxicities with studytreatment and cannot be changed to alternative agents.

• Any condition that, in the opinion of the investigator, would impair theparticipants' ability to comply with the study procedures or study treatment (e.g.,unable to swallow study treatment).

• Unwilling or unable to comply with all protocol-required visits and assessments orcomply with study requirements.

• Prior treatment with:

• Second-generation androgen receptor (AR) inhibitors (such as enzalutamide,apalutamide, darolutamide, proxalutamide, etc)

• Other investigational AR inhibitors

• Cytochrome P450 (CYP17) enzyme inhibitors (such as oral ketoconazole,abiraterone acetate, TAK-700, etc).

• Use of first-generation AR inhibitors (bicalutamide, flutamide, nilutamide,cyproterone acetate) within 28 days before first dose of study treatment.

• Use of estrogens or 5-α reductase inhibitors (finasteride, dutasteride) within 28days before first dose of study treatment.

• Prior chemotherapy or immunotherapy for prostate cancer, except adjuvant/neoadjuvanttreatment completed > 2 years before first dose of study treatment.

• Use of systemic corticosteroid with dose greater than the equivalent 10 mg ofprednisone/day within 28 days before first dose of study treatment.

• Radiation therapy (external beam radiation therapy, brachytherapy, orradiopharmaceuticals) within 12 weeks before first dose of study treatment.

• Treatment with an osteoclast-targeted therapy (bisphosphonate or denosumab) toprevent skeletal-related events within 4 weeks before first dose of study treatment.Participants receiving osteoclast-targeted therapy to prevent bone loss at a doseand schedule indicated for osteoporosis may continue treatment at the same dose andschedule.

• Treatment with any investigational drug within 28 days before first dose of studytreatment.