Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.

Pts must have adeno ca of the prostate (small cell or neuroendocrine not allowed) which is metastatic as evidenced by soft tissue and/or bony mets at time of initiation of androgen deprivation (AD). Zubrod PS 0-2. Pt must be rec'g AD prior to reg (bilateral surgical orchiectomy is acceptable). Pt must have suboptimal response to AD as defined in Sect 5.4. Meas dis assessed by abd/pelv CT w/in 28 d prior reg. Non-meas dx assessed by bone scan w/in 42 d prior to reg. Hx of prior neoadj or adj GNRH agonist/antagonist therapy ok provided > 2 yrs prior reg. Prior finasteride or dutasteride ok if d/c'd > 6 wks prior reg. Prior enrollment to S0925 is not exclusionary. No prior chemo, radiopharmaceutical, ketoconazole for PCa. Pt must not require > 10 mg prednisone for other indications. Pt must not have received any prior Provenge. Prior RT or surgery ok provided > 28 days since completion and recovered from side effects. No plans to receive concurrent chemo, surgery or RT. No hormonal-acting agents. Pt must d/c antiandrogen therapy prior to reg. See Sect 5.4 for wash-out requirements. No hx or current brain mets. Pts w/clinical evidence of brain mets must have negative brain CT or MRI w/in 56 d prior to reg. Testosterone < 50, ANC >/= 1,500, PLT >/= 100,000, Hg >/= 10, creat < 1.5 x ULN or calc CrCl >/= 60, bili <1.5 ULN, SGOT & SGPT <1.5 ULN, potassium >/= 3.5 w/in 28 days prior to reg. Pts must be able to take oral meds. Pts must not have hx of GI disorders that may interfere w/ absorption of abiraterone acetate. Pt w/active or symptomatic viral hep, chronic liver dx or Child-Pugh B or C hepatic impairment are not eligible. Pt must have well controlled BP. No history of NY Heart Assoc Class III and IV heart failure. No other prior malignancy except as defined in Sect 5.22. Pt must be willing to use BC w/adequate barrier protection during and for 1 wk after last study drug administration.