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