_

• Conditions: metastatic hormone-naïve prostate cancer; MedDRA version: 18.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000142-35-GR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-04
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 916

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate,
2. Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:
o At least one extra-pelvic lymph node = 2 cm
or
o extra-pelvic lymph node (s) = 1 cm if the patients also have at least one pelvic lymph node = 2 cm
3. Patients with ECOG = 1 (patient with PS 2 due to bone pain can be accrued in the trial),
4. Life expectancy of at least 6 months,
5. Male aged = 18 years old,
6. Hemoglobin = 10.0 g/dL,
7. Platelet count = 100,000/µL,
8. Renal function: serum creatinine < 1.5 x ULN or a calculated creatinine clearance = 60 mL/min,
9. Serum potassium > 4 mmol/L,
10. Liver function: Serum bilirubin = 1.5 x ULN (except for patients with documented Gilbert’s disease); AST and ALT = 2.5 x ULN (and = 5 ULN in case of liver metastases),
11. Patients might have received a maximum of 3 months of androgen deprivation therapy (ADT) before randomization,
12. Patients might have received previous radiation therapy directed to bone lesions, as far as it is terminated by the time of randomization,
13. Patients able to take oral medication,
14. Patients who have received the information sheet and signed the informed consent form,
15. Male patients who are receiving the study treatment and have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment,
16.Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
17.Patients with a public or a private health insurance coverage, according to the local laws for partipation in clinical trials
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 458
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 458

Exclusion Criteria

1. Patients with previous local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, or other). A previous trans-urethral resection of the prostate (TURP) is allowed,
2. Prior cytotoxic chemotherapy or biological therapy for the treatment of CRPC,
3. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
4. Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contraindicated,
5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
7. Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg),
8. Patients with a history of hypertension that is not controlled by anti-hypertensive treatment,
9. Severe hepatic impairment or moderate hepatic impairment (Child – Pugh class C or B)
10. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert’s disease),
11. History of pituitary or adrenal dysfunction,
12. Pathological finding consistent with small cell carcinoma of the prostate,
13. Clinically known 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,
14. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
15. Other malignancy, except non-melanoma skin cancer, with a = 30% probability of recurrence within 24 months,
16. Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
17. Administration of an investigational therapeutic within 30 days of M1 D1,
18. Patients already included in another therapeutic trial involving an experimental drug,
19. Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
20. Individual deprived of liberty or placed under the authority of a tutor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified