Clinical trial NCT00473746 (phase 1/phase 2, status: completed)
Conditions: prostate neoplasms
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: abiraterone acetate, abiraterone acetate, prednisone/prednisolone or dexamethasone
SMILES: [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

        Phase 1

          -  Histologically confirmed adenocarcinoma of the prostate

          -  No prior therapy with chemotherapy for prostate cancer

          -  Ongoing gonadal androgen deprivation therapy with luteinizing hormone-releasing
             hormone (LHRH) analogues or orchiectomy

          -  Testosterone <50 ng/dL

          -  Progressive disease after androgen deprivation

          -  The presence of objective metastatic disease is NOT required for study eligibility

          -  Demonstrate disease progression after antiandrogen withdrawal

          -  Eastern Cooperative Oncology Group (ECOG) performance status score = 0-1

          -  Laboratory values within protocol-defined parameters

          -  Systolic blood pressure <160 mmHg and diastolic blood pressure <110mmHg documented on
             at least 3 different days

          -  Baseline adrenocorticotropic hormone (ACTH) stimulation test demonstrating a peak
             cortisol >18 µg/dL

          -  Agrees to protocol-defined use of effective contraception

          -  Life expectancy of >=12 weeks

        Phase 2

          -  Same as Phase 1 criteria with addition of following criteria

          -  Neoadjuvant or adjuvant chemotherapy is only allowed if the last dose is >1 year from
             Cycle 1 Day 1

          -  Target or non-target abnormalities must be present either on screening bone scan,
             computed tomography or magnetic resonance imaging

          -  No prior treatment with ketoconazole for the management of androgen independent
             prostate cancer

        Exclusion Criteria:

        Phase 1

          -  Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace),
             finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease
             prostate specific antigen (PSA) levels (eg, saw palmetto and PC-SPES), or any systemic
             corticosteroid within 4 weeks prior to first dose of study drug

          -  Initiation of bisphosphonate therapy within 4 weeks prior to first dose of study drug

          -  Therapy with supplements or complementary medicines/botanicals within 4 weeks of first
             dose of study drug, except for any combination of the following: conventional
             multivitamin supplements, selenium, lycopene, soy supplements

          -  Prior radiation therapy completed <4 weeks prior to enrollment

          -  Prior chemotherapy for hormone refractory prostate cancer

          -  Any currently active second malignancy, other than non-melanoma skin cancer

          -  Systolic blood pressure >=160 mmHg or diastolic blood pressure >=110 mmHg measured on
             at least 2 occasions

          -  NYHA Class III or IV congestive heart failure

          -  Myocardial infarction within the 6 months prior to the first dose of study drug

          -  Serious intercurrent infections or nonmalignant medical illnesses that are
             uncontrolled

          -  Active psychiatric illnesses/social situations that would limit compliance with
             protocol requirements

          -  Active or uncontrolled autoimmune disease that may require corticosteroid therapy
             during study

        Phase 2

          -  Same as phase 1 with the following addition

          -  Abnormal electrocardiogram, including any finding which would interfere with
             assessment of intervals (patients with long QT syndrome, bundle branch blocks or
             hemiblocks are prohibited)