Clinical trial NCT02077634 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: abiraterone acetate + prednisone + lhrh-therapy, abiraterone acetate + prednisone
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
Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent

          2. Written Data Protection Consent has been obtained

          3. Male aged 18 years and above

          4. Histologically or cytologically confirmed adenocarcinoma of the prostate

          5. Metastatic disease documented by positive CT/MRI and/or bone scan (both must be
             performed). If lymph node metastasis is the only evidence of metastasis, it must be ≥2
             cm in diameter

          6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic
             progression according to modified RECIST criteria

          7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 for the
             question of worst pain within last 24 hours (Appendix 8) will be considered
             asymptomatic, and a score of 2-3 will be considered mildly symptomatic.

          8. Medically castrated, with testosterone levels of <20-50 ng/dl (< 2.0 nM).

          9. Combined androgen blockade is permitted, but not required. If patients received
             combined androgen blockade with an anti-androgen they must have shown PSA progression
             after discontinuing the anti-androgen prior to enrollment (≥4 weeks since last
             flutamide, ≥6 weeks since last bicalutamide or nilutamide).

         10. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2 (Appendix 6)

         11. Hemoglobin ≥9.0 g/dL independent of transfusion

         12. Platelet count ≥100,000 /μl

         13. Serum albumin ≥3.0 g/dl

         14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥60 ml/min (Appendix
             7)

         15. Serum potassium ≥3.5 mmol/l

         16. Liver function:

               1. Serum bilirubin <1.5 x ULN (except for patients with documented Gilbert's
                  disease)

               2. AST or ALT <2.5 x ULN

         17. Able to swallow the study drug whole as a tablet

         18. Life expectancy of at least 6 months

         19. 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 and sponsor during the study and for 1 week after last
             study drug administration.

        Exclusion Criteria:

          1. Surgical castration (i.e. orchiectomy).

          2. Application of any LHRH-therapy (LHRH-analogue or LHRH-antagonist) within 3 months
             (for patients receiving a 3-months formulation) or 1 months (for patients receiving a
             1-month formulation) prior to Cycle 1 day 1.

          3. Patients receiving a 6- or 12-months formulation of LHRH-therapy

          4. Active infection or other medical condition that would make prednisone/prednisolone
             (corticosteroid) use contraindicated

          5. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg
             prednisone/prednisolone bid.

          6. Pathological finding consistent with small cell carcinoma of the prostate

          7. Liver or visceral organ metastasis

          8. Known brain metastasis

          9. Use of opiate analgesics for cancer-related pain, including codeine, tramadol, tilidin
             and others (see Appendix 9), currently or anytime within 4 weeks of Cycle 1 Day 1.

         10. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

         11. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1

         12. Radiation or radionuclide therapy for treatment of metastatic CRPC

         13. Prior treatment with Abiraterone acetate or other CYP17 inhibitors (ketoconazole,
             TAK700, TOK001) ), Enzalutamide (Xtandi) or investigational agents targeting the
             androgen receptor for prostate cancer for more than 7 days

         14. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4
             weeks of Cycle 1, Day 1

         15. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose
             PSA did not decline for three or more months in response to antiandrogen given as a
             second line or later intervention will require only a two week washout prior to Cycle
             1, Day 1)

         16. Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1
             (patients whose PSA did not decline for three or more months in response to
             antiandrogen given as a second line or later intervention will require only a two week
             washout prior to Cycle 1, Day1)

         17. Uncontrolled hypertension (systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg). Patients
             with a history of hypertension are allowed provided that blood pressure is controlled
             by anti- hypertensive treatment

         18. Active or symptomatic viral hepatitis or chronic liver disease

         19. History of pituitary or adrenal dysfunction

         20. Clinically significant heart disease as evidenced by myocardial infarction, or
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New
             York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
             measurement of <50 % at baseline

         21. Any condition that requires treatment with Digoxin, digitoxin, and other digitalis
             drugs

         22. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy

         23. Other malignancy with a ≥30 % probability of recurrence within 24 months, except non-
             melanoma skin cancer.

         24. Administration of an investigational therapy within 30 days of Cycle 1, Day 1

         25. Any condition, which, in the opinion of the investigator, would preclude participation
             in this trial.