prostate cancer
Conditions
Interventions
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology;2. Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging scan;3. At least two of the following high-risk prognostic factors: Gleason score of *8; presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI scan;4. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2;5. Adequate hematologic, hepatic, and renal function;6. Agrees to protocol-defined use of effective contraception
Exclusion criteria
Exclusion criteria: 1. Active infection or other medical condition that would make prednisone use contraindicated;2. Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day;3. Pathological finding consistent with small cell carcinoma of the prostate;4. Known brain metastasis;5. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer; the following exceptions are permitted: up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or orchiectomy with or without concurrent anti-androgens prior to Cycle 1 Day 1; patients may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1, all adverse events associated with these procedures must be resolved at least to Grade 1 by Cycle 1 Day 1.;6. Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic BP >=95 mmHg; patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment);7. Active or symptomatic viral hepatitis or chronic liver disease, ascites or bleeding disorders secondary to hepatic dysfunction.;8. History of adrenal dysfunction;9. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events or history of cardiac failure in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease ;10. Atrial fibrillation, or other cardiac arrhythmia requiring pharmacotherapy;11. Other malignancy (within 5 years), except non-melanoma skin cancer;12. Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 28 days of Cycle 1 Day 1 or currently enrolled in an investigational study;13. Any condition or situation which, in the opinion of the investigator, would put the patient at risk, may confound study results, or interfere with the patient*s participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY EVALUATIONS: with protocol amendment INT-2 dd 18 April 2014 the radiographic progression-free survival (rPFS) was added as a co-primary endpoint with overall survival (OS) Efficacy Endpoints Co-primary endpoint: rPFS and OS Overall survival (OS) is defined as the time from randomization to date of death from any cause. Survival data will be collected throughout the Double-blind Treatment Phase and during the Follow-up Phase. Once a subject has completed the Double-blind Treatment Phase, OS follow-up will be performed every 4 months for up to 60 months (5 years) or until subject death, lost to follow-up, withdrawal of consent, or study termination. rPFS is defined as the time from randomization to the occurence of radiographic progression or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: time to next skeletal related event, time to prostate specific antigen (PSA) progression, time to next subsequent therapy for prostate cancer, time to initiation of chemotherapy and time to pain progression. Exploratory: PSA response rate, PRO measures (EQ-5D-5L [Euro-QoL], Brief Pain Inventory-Short Form [BPI-SF], Functional Assessment Cancer Therapy-Prostate [FACT-P], Brief Fatigue Inventory [BFI]), pain measures (time to pain progression), time to symptomatic local progression defined as occurrence of urethral obstruction or bladder outlet obstruction, and prostate cancer specific survival. | — |
Countries
Netherlands
Outcome results
None listed