A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance

Inclusion Criteria:

intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive,

≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.

a. Condom (barrier method of contraception)

AND

b. One of the following is required:

i. Established use of oral, injected or implanted hormonal methods of

contraception by the female partner;

ii. Placement of an intrauterine device or intrauterine system by the female partner;

iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.

Exclusion Criteria:

a. Myocardial infarction or uncontrolled angina within 6 months

b. Congestive heart failure New York Heart Association (NYHA) class 3 or 4

c. History of clinically significant ventricular arrhythmias

d. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place

e. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening

f. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination

g. Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit