3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy

Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.

Male aged 18 years and above

Patients must have undergone local treatment via radical prostatectomy

Patients who have received primary radiation therapy followed by a salvage radical prostatectomy are eligible.

Patients who have had post-operative radiation therapy for presumed locally recurrent disease are eligible

Histologically confirmed prostate cancer (per standards at Institution of participant registration) currently with progressive disease, defined as:

Rising PSA (50% or more increase to a level of 1 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential AND

PSADT ≤ 9 months as calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm) OR

Rising PSA as defined above AND

Metastatic disease limited to the presence of pelvic and/or retroperitoneal nodes \< 2 cm in short axis.

Patients must have a serum testosterone of 150 ng/dL or greater

ECOG performance status of ≤ 2 (Appendix A)

Adequate bone marrow, hepatic, and renal function, as evidenced within 14 days prior to treatment initiation by:

Absolute neutrophil count (ANC) ≥ 1500/mm3

Platelet count ≥ 100,000/mm3

Hemoglobin ≥ 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation

Aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of the normal range (x ULN)

Alanine aminotransferase (ALT) ≤ 1.5 x ULN

Total bilirubin ≤ 1.5 x ULN

Serum creatinine of ≤ 1.5 mg/dl or Calculated creatinine clearance of ≥ 60 mL/min

Serum albumin ≥ 3.0 g/dL

Serum potassium ≥ 3.5 mEq/L

Prothrombin time (PT) ≤ 1.5 x ULN (or international normalized ratio \[INR\] ≤ 1.3) unless the patient is receiving anticoagulant therapy

Partial thromboplastin time (PTT) ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy At least 4 weeks and recovery to Grade 0-1 from reversible effects of prior surgery (i.e., incisional pain, wound drainage)

Able to swallow the study drug whole as a tablet

Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken

Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator during the study and for 1 week after last dose of abiraterone acetate.

What this study is about