The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer

Key Inclusion Criteria:

- Histologically proven adenocarcinoma of the prostate

- Rising PSA after prior definitive local therapy (radical prostatectomy, external beam
radiation, or brachytherapy) or combination of radical prostatectomy and radiotherapy
with curative intent

- PSA doubling time less than or equal to 12 months

- No evidence of metastatic disease on imaging by whole body bone scan and computerized
tomography (CT) or Magnetic Resonance Imaging (MRI) of the abdomen/pelvis within 6
weeks prior to randomization

- Minimum PSA 1.0 ng/mL if prior radical prostatectomy +/- adjuvant or salvage
radiation; nadir + 2.0 ng/mL if prior RT without prior radical prostatectomy

- Prior androgen deprivation therapy (ADT) allowed if last dose was greater than (>) 6
months prior to randomization

- No prior androgen deprivation therapy (ADT) or anti-androgen for biochemical relapse

- Serum testosterone > 150 ng/dL at study entry

- No history of seizures or medical conditions which may lower seizure threshold

Key Exclusion Criteria:

- Use of 5-alpha reductase antagonist (i.e. finasteride, dutasteride) within 6 weeks
prior to randomization

- Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 6 weeks prior to
randomization

- Prior bilateral orchiectomy

- Prior treatment with ADT for biochemically relapsed prostate cancer. Prior ADT as
neo-adjuvant, concurrent, and/or adjuvant treatment following salvage radiation
therapy or prostatectomy for biochemically relapsed disease is allowed provided last
dose of ADT is greater than (>) 6 months prior to randomization and the Screening
serum testosterone level is greater than or equal to (≥)150 ng/dL

- Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at
randomization

- Any history of seizures or medical condition which lowers seizure threshold