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
- bonemetastases in patients with hormone refractory prostate cancerprostate cancer spread to bone1000595910038588
- Registration Number
- NL-OMON31761
- Lead Sponsor
- AMGEN, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- Men >= 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 >= 0.4 ng/mL and be 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:
-aspartate aminotransferase (AST) <= 5 x upper limit of normal (ULN)
-alanine aminotransferase (ALT) <= 5 x ULN
-total bilirubin <= 2 x ULN
-creatinine clearance (Cockcroft-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 is performed, the appropriate written informed consent must be obtained
- Current or prior IV bisphosphonate administration for any reason ;- Current or prior oral bisphosphonate administration for the treatment of bone metastasis;- Planned radiation therapy or surgery to bone ;- Prior administration of denosumab;- Known brain metastases ;- 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:
-known history of second malignancy within the past 3 years, except for basal cell carcinoma
-known infection with human immunodeficiency virus
-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 the study (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to the first on-study SRE (non-inferiority)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time to the first on-study SRE (superiority)<br /><br><br /><br>Time to the first-and-subsequent on-study SRE (superiority, using multiple<br /><br>event analysis)<br /><br><br /><br>Subject incidence of treatment-emergent adverse events<br /><br><br /><br>Changes in laboratory values<br /><br><br /><br>Incidence of anti-denosumab antibody (binding and neutralizing) formation</p><br>