Prevention of bone metastases in hormone refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10005993 Term: Bone metastases
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men with histologically confirmed prostate cancer -Age = 18 years -Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 -Chemical or surgical castration defined as: • bilateral orchiectomy (also referred to as orchidectomy) at least 6 months before randomization, OR • continuous androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) agonist or antagonist for at least 6 months before randomisation -Total serum testosterone level of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Prior or current evidence of radiographically detectable bone metastasis -Known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable) -Prior or current IV bisphosphonate administration -Prior or current use of oral bisphosphonates as follows: • Greater than or equal to 3 years continuously • Greater than 3 months but less than 3 years (eligible if subject has a 1 year washout before randomisation) -Prior administration of AMG 162 -Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw -Evidence of any of the following conditions per subject self report or medical chart review: • Any prior malignancy (other than treated basal cell skin cancer), within 5 years before randomization • Major surgery or significant traumatic injury occurring within 4 weeks before randomisation • Active infection with Hepatitis B virus or Hepatitis C virus • Known infection with human immunodeficiency virus (HIV) -Any major medical 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 investigational product or device in another clinical trial. -Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the treatment effect of AMG 162 with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.;Secondary Objective: To compare the treatment effect of denosumab with placebo on: • time to first bone metastasis excluding deaths • overall survival To assess the safety and tolerability of denosumab compared with placebo.;Primary end point(s): Bone metastasis-free survival determined by the time to first occurrence of bone metastasis (either symptomatic or asymptomatic) or death from any cause | — |
Countries
Belgium, Bulgaria, Czech Republic, Finland, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Portugal, Slovakia, Spain, United Kingdom
Outcome results
None listed