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

Inclusion Criteria

• •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)