| Exclusion Criteria: | 1) Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
2) Hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (ADT) prior to or concurrent with primary therapy. Subjects who underwent neoadjuvant ADT must have a serum testosterone of >150 ng/mL at study entry.
3) Concomitant or antecedent hormonal therapy for rising serum PSA after initial therapy of prostate cancer.
4) Subjects unable or unwilling to comply with protocol requirements.
5) Prior treatment with experimental drugs, high dose steroids, or with any drug or therapy with the potential to impact prostate cancer or PSA within 6 months prior to the first dose of study product and for the duration of the study.
6) Serum PSA >7.0 ng/mL (assessed at termination of the double-blind study; at any PSA level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
7) Serum PSA doubling time <13 weeks (assessed at termination of the double-blind study).
8) Evidence of metastatic disease on physical examination or on CT or bone scan.
9) Use of finasteride, dutasteride at any point since primary therapy or during the study.
10) Clinically significant abnormal laboratory value (other than PSA) greater than 2 times the upper limit of normal (>2XULN). |