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 by CT/MRI abdomen/pelvis and whole body bone scan

- 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

- No androgen deprivation therapy or anti-androgen (i.e. bicalutamide) within 12 months
of study entry

- 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 3 months
of study entry

- Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within 12 months of
study entry

- Prior bilateral orchiectomy

- Prior hormonal treatment with ADT or antiandrogen for biochemically relapsed prostate
cancer

- Use of systemic steroids at an equivalent dose of prednisone 5 mg/day or higher at
the time of study entry

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