Clinical trial NCT02849990 (phase 2, status: completed)
Conditions: stage iii prostate adenocarcinoma ajcc v7, stage iii prostate cancer ajcc v7, stage iv prostate adenocarcinoma ajcc v7, stage iv prostate cancer ajcc v7
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: abiraterone acetate, apalutamide, degarelix, indomethacin, prednisone
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Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Documented histologically confirmed adenocarcinoma of the prostate

          -  Willing to undergo prostatectomy as primary treatment for localized prostate cancer

          -  High risk prostate cancer (per National Comprehensive Cancer Network [NCCN] criteria):
             Gleason score 8-10 or T3a or PSA > 20 ng/mL or very-high risk prostate cancer (per
             NCCN criteria): T3b-T4

          -  Serum testosterone >= 150 ng/dL

          -  Able to swallow the study drugs whole

          -  Willing to take abiraterone acetate on an empty stomach (no food should be consumed at
             least two hours before and for one hour after dosing)

          -  Agrees to use a condom (even men with vasectomies) and another effective method of
             birth control if he is having sex with a woman of childbearing potential or agrees to
             use a condom if he is having sex with a woman who is pregnant while on study drug and
             for 3 months following the last dose of study drug; must also agree not to donate
             sperm during the study and for 3 months after receiving the last dose of study drug

          -  Medications known to lower the seizure threshold (see list under prohibited meds) must
             be discontinued or substituted at least 4 weeks prior to study entry

        Exclusion Criteria:

          -  Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation
             therapy, brachytherapy)

          -  Prior use of apalutamide, abiraterone acetate or degarelix

          -  Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

               -  Hormonal therapy (for example [e.g.] leuprolide, goserelin, triptorelin,
                  degarelix)

               -  Cytochrome P450 (CYP)-17 inhibitors (e.g. ketoconazole)

               -  Antiandrogens (e.g. bicalutamide, nilutamide)

               -  Second generation antiandrogens (e.g. enzalutamide, apalutamide)

               -  Immunotherapy (e.g. sipuleucel-T, ipilimumab)

               -  Chemotherapy (e.g. docetaxel, cabazitaxel)

          -  Evidence of serious and/or unstable pre-existing medical, psychiatric or other
             condition (including laboratory abnormalities) that could interfere with patient
             safety or provision of informed consent to participate in this study

          -  Any psychological, familial, sociological, or geographical condition that could
             potentially interfere with compliance with the study protocol and follow-up schedule

          -  Absolute neutrophil count [ANC] < 1500/mm^3

          -  Platelet count < 100,000/mm^3

          -  Hemoglobin < 9 g/dL

          -  Total bilirubin > 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5 x ULN; Note:
             in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct
             and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be
             eligible

          -  Abnormal kidney function (glomerular filtration rate GFR < 45 mL/min)

          -  Serum albumin < 3 g/dL

          -  Serum potassium < 3.5 mmol/L

          -  Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1
             year to randomization, brain arteriovenous malformation, schwannoma, meningioma, or
             other benign central nervous system [CNS] or meningeal disease which may require
             treatment with surgery or radiation therapy)

          -  Severe or unstable angina, myocardial infarction, symptomatic congestive heart
             failure, arterial or venous thromboembolic events (eg, pulmonary embolism,
             cerebrovascular accident including transient ischemic attacks), or clinically
             significant ventricular arrhythmias within 6 months prior to randomization

          -  History of stroke within the last 5-years

          -  History of gastrointestinal (GI) bleed requiring transfusion

          -  History of peptic ulcer disease requiring treatment within the last 5-years

          -  History of asthma that is nonsteroidal anti-inflammatory drug (NSAID)-induced or with
             asthma that is classified as 'mild-persistent' or worse (based on symptoms occurring
             more than 2 days per week)

          -  Uncontrolled hypertension

          -  Gastrointestinal disorder affecting absorption

          -  Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)

          -  Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg
             prednisone/ prednisolone once daily

          -  Any condition that in the opinion of the investigator, would preclude participation in
             this study

          -  Child Pugh class B & C

          -  Pre-existing viral hepatitis