A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer
- Conditions
- Treatment of bone metastases in men with hormone- refractory prostate cancerMedDRA version: 14.1Level: 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
- EUCTR2006-000341-19-IT
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1700
men with histologically or cytologically-confirmed prostate cancer current or prior radiographic (x-ray, magnetic resonance imaging [MRI] or computer tomography [CT]) evidence of at least 1 bone metastasis documented failure of at least one hormonal therapy as evidenced by a rising PSA (ie, 3 consecutive determinations, taken at least 2 weeks apart from one another, with the third measurement being 4.0 ng/dL and taken within 8 weeks prior to randomization) serum testosterone level of < 50 ng/dL due to either surgical or chemical castration administration of concurrent chemotherapy or hormonal therapy for metastatic prostate cancer is allowed during the study, however, the therapy must be initiated and remain unchanged 28 days or more before randomization to the study life expectancy > 6 months Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 adequate organ function as defined by the following criteria: - serum aspartate aminotransferase (AST) 5 x upper limit of normal (ULN) - serum alanine aminotransferase (ALT) 5 x ULN - serum total bilirubin 2 x ULN - creatinine clearance (Cockroft-Gault) 30 mL/min - albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL) before any study-specific procedure, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
current or prior IV bisphosphonate administration. Prior administration of oral bisphosphonates is allowed, but they must be discontinued prior to randomization to the study. prior administration of denosumab known brain metastases known impending fracture in the hip region, defined as evidence of osteolytic lesions with cortical bone destruction exceeding 50% in the femur history or current evidence of osteomyelitis or osteonecrosis of the jaw active dental or jaw condition that requires oral surgery Non healed dental/oral surgery planned invasive dental procedures (eg, tooth extraction) for the course of the study evidence of any of the following conditions per subject self report or medical chart review: - history of, or concurrent malignancy (other than prostate cancer, superficial bladder cancer (ie, stage < T1G3), or basal cell carcinoma) if active disease is <3 years before date of randomization - unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization - major surgery (including surgery to bone), or significant traumatic injury occurring within 4 weeks before randomization - known infection with human immunodeficiency virus - active infection with Hepatitis B virus or Hepatitis C virus any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results thirty days or less since receiving an unapproved (ie, no marketing authorization has been granted in that country) product or device in another clinical trial known sensitivity to any of the products to be administered during the study (eg,zoledronic acid, mammalian derived products, calcium or vitamin D)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -To compare the treatment effect of denosumab with zoledronic acid on the first occurrence of either a skeletal-related event (SRE) in men with hormone-refractory prostate cancer and bone metastases;Secondary Objective: -To compare the treatment effect of denosumab with zoledronic acid on the first occurrence of an SRE or hypercalcemia of malignancy (HCM) -To compare the treatment effect of denosumab with zoledronic acid on the first use of radiation to bone -To compare the treatment effect of denosumab with zoledronic acid on first-and-subsequent SRE (multiple- event analysis) -To compare the treatment effect of denosumab with zoledronic acid on pain and analgesic use -To assess the safety and tolerability of denosumab compared with zoledronic acid;Primary end point(s):  time to the first on-study SRE (ie, fracture [vertebral and nonvertebral], radiation therapy to bone [including use of radioisotopes], surgery to bone, or spinal cord compression) or HCM
- Secondary Outcome Measures
Name Time Method