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 cancer.
- Registration Number
- EUCTR2006-000341-19-HU
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1700
-Men greater than or equal to 18 years of age with histologically-confirmed prostate cancer.
-Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) 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. The third measurement must be greater than or equal to 0.4 ng/mL and taken within 8 weeks prior to randomization).
-Serum testosterone level of < 50 ng/dL due to either surgical or chemical castration
-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
-Adequate organ function as defined by the following criteria:
1. aspartate aminotransferase (AST) less than or equal to 5 x institutional upper limit of normal (ULN)
2. alanine aminotransferase (ALT) less than or equal to 5 x ULN
3. total bilirubin less than or equal to 2 x ULN
4. creatinine clearance (Cockcroft-Gault) greater than or equal to 30 mL/min
5. albumin-adjusted serum calcium greater than or equal to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 2.9 mmol/L (11.5 mg/dL)
-Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-Current or prior IV bisphosphonate administration for any reason
-Current or prior oral bisphosphonate administration for the treatment of bone metastases
-Planned radiation therapy or surgery to bone
-Prior administration of denosumab
-Known brain metastasis
-Life expectancy less than 6 months
-Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
-Active dental or jaw condition that requires oral surgery
-Non-healed dental/oral surgery
-Planned invasive dental procedure(s) for the course of the study
-Evidence of any of the following conditions per subject self report or medical chart review:
1. Known history of second malignancy within the past 3 years, except for basal cell carcinoma
2. Known infection with human immunodeficiency virus
3. Active infection with hepatitis B or hepatitis C virus
-Any 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 investigational product or device (ie, does not have marketing authorization) in another clinical trial
-Subject with reproductive potential who will not agree to use effective contraception (as defined by the investigator or designee)
-Known sensitivity to any of the products to be administered during dosing (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 determine if denosumab is non-inferior to zoledronic acid (Zometa) with respect to the first on-study occurrence of a skeletal-related event (SRE) in subjects with hormone-refractory prostate cancer and bone metastases. SRE is defined as pathological fracture (vertebral or nonvertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.;Secondary Objective: -To determine if denosumab is superior to zoledronic acid with respect to first on-study SRE.<br>-To determine if denosumab is superior to zoledronic acid with respect to first-and-subsequent on-study SRE (multiple event analysis).<br>To assess the safety and tolerability of denosumab compared with zoledronic acid.<br>;Primary end point(s): Time to the first on-study SRE (non-inferiority).
- Secondary Outcome Measures
Name Time Method