S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Criteria the registry did not label

• DISEASE CHARACTERISTICS:
• Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
  • Metastatic (M1) disease as evidenced by soft tissue and/or bony metastases at the time of initiation of androgen-deprivation therapy (ADT)
  • Must have at least one of the following:
  • Visceral disease (liver, lung, other viscera)
  • Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton
  • Distant lymph node disease (e.g., above the aortic bifurcation, etc.)
  • No small cell or neuroendocrine prostate cancer
• Patients must be receiving ADT (e.g., gonadotropin-releasing hormone \[GNRH\] antagonist, with or without antiandrogen) prior to entering this study
  • Degarelix, a FDA-approved GNRH antagonist, is an acceptable form of ADT
  • Bilateral surgical orchiectomy is also acceptable
• Suboptimal response to ADT induction as defined by the following criteria:
  • Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT
  • PSA of \> 4 ng/mL must be observed between 6-12 months after the initiation of ADT
  • Documentation of failure to achieve this PSA of ≤ 4 ng/mL must be within 28 days of registration
  • The PSA must be obtained after any applicable antiandrogen washout period
  • If the PSA is declining or stable (defined as a PSA rise ≤ 0.1 ng/mL from nadir) and the patient is on an antiandrogen, they must remain on the antiandrogen
  • Patients with stable or declining PSA who have had previous antiandrogen exposure, but are not taking an antiandrogen at the time of registration, must wait at least 6 weeks from the last antiandrogen dose before registration and still demonstrate a stable or falling PSA which is \> 4 ng/mL by month 12, in order to be eligible
  • If the PSA is rising and they are on an antiandrogen, formal antiandrogen washout must be performed (4 weeks for flutamide and 6 weeks for bicalutamide and nilutamide with no evidence of a falling PSA after washout)
  • No patients with radiographic progression when compared to available imaging studies performed prior to starting the GNRH agonist/antagonist therapy
• Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic CT scan) within 28 days prior to registration
• Non-measurable disease must be assessed (i.e., bone scan) within 42 days prior to registration
• No patients with a history of brain metastases or who currently have treated or untreated brain metastases
  • Patients with clinical evidence of brain metastases must have a brain CT scan or MRI negative for metastatic disease within 56 days prior to registration
  • PATIENT CHARACTERISTICS:
• Zubrod performance status 0-2
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 10 g/dL
• Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
• Bilirubin ≤ 1.5 times ULN (unless documented Gilbert disease)
• AST and ALT \< 1.5 times ULN
• Potassium ≥ 3.5 mmol/L
• Patient must have a testosterone value of \< 50 ng/dL obtained within 28 days prior to registration
• Patients must have controlled blood pressure defined as systolic blood pressure \< 160 mm Hg and diastolic blood pressure \< 95 mm Hg
  • Patients with a history of hypertension are eligible provided blood pressure is controlled by anti-hypertensive treatment
• Patients who have partners of child-bearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last study drug administration
• Must be able to take oral medication without crushing, dissolving, or chewing tablets
• Patients must not have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of abiraterone acetate
• No other prior malignancy is allowed except for any of the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated stage I or II cancer from which the patient is currently in complete remission
  • Any other cancer from which the patient has been disease-free for 5 years
• No patients with active or symptomatic viral hepatitis or chronic liver disease
  • No moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• No history of NYHA class III or IV heart failure
  • Patients must have LVEF ≥ 50%
• No known allergies, hypersensitivity, or intolerance to abiraterone acetate, prednisone, or their excipients
  • PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Patients with a history of prior neoadjuvant or adjuvant GNRH agonist/antagonist therapy (related to previous surgery or radiation) are eligible provided they finished this therapy at least two years prior to registration
  • Prior enrollment to SWOG-S0925 (either arm) is not exclusionary
• At least 6 weeks since prior and no concurrent finasteride or dutasteride
• At least 28 days since prior radiotherapy or surgery and recovered
• At least 4 weeks since prior investigational products
• At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA
  • No other concurrent oral antiandrogen
• No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer
• No prior or concurrent ketoconazole for the treatment of prostate cancer
• Not requiring more than 10 mg a day of prednisone for another medical indication
• Not planning to receive any concurrent cytotoxic chemotherapy, immunotherapy, surgery, or radiotherapy during protocol treatment
• No concurrent hormonal-acting agents, including diethylstilbestrol/DES, aldosterone, PC-SPES, or spironolactone
• No concurrent antifungal medication (e.g., fluconazole or itraconazole)
• No medications that alter cardiac conduction
• No prior Provenge (sipuleucel-T)