ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The
study population will consist of approximately 1300 subjects with metastatic hormone
sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x
300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a
total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and
docetaxel. Subjects will be stratified at randomization for the extent of disease and for
Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six
cycles of docetaxel will be administered after randomization.

The subjects considered for inclusion in the study will have metastatic prostate cancer and
will be candidates for ADT and docetaxel.

Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic
progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject
withdraws consent, withdrawal from the study at the discretion of the Investigator or his/her
designated associate(s), death, non-compliance, or if Sponsor terminates the study.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of prostate.

- Metastatic disease

- Candidates for ADT and docetaxel. Started ADT with or without first generation anti
androgen, but no longer than 12 weeks before randomization

- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor
(AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201); other
investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or
oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or
immunotherapy for prostate cancer prior to randomization.

- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.

- Had any of the following within 6 months before randomization: stroke, myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
congestive heart failure (New York Heart Association Class III or IV)

- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of
skin or 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 which
treatment has been completed 5 years before randomization and from which the subject
has been disease-free

- Gastrointestinal disorder or procedure which is expected to interfere significantly
with absorption of study treatment.

- Inability to swallow oral medications