Status:
COMPLETED
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Lead Sponsor:
Amgen
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer...
Detailed Description
Participants were randomized to receive denosumab 120 mg or placebo every 4 weeks (Q4W) until approximately 660 participants developed bone metastasis or died and the primary efficacy and safety analy...
Eligibility Criteria
Inclusion
- men with histologically confirmed prostate cancer
- bilateral orchiectomy 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 randomization
- total testosterone level less than 50 ng/dL,
- hormone refractory (androgen independent) prostate cancer demonstrated during continuous ADT/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (PSA) values with PSA1 \< PSA2 \< PSA3, each PSA value must be separated by at least 2 weeks, PSA2 and PSA3 greater than or equal to 1.0 ng/mL,
- high risk for development of bone metastasis defined as PSA value greater than or equal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSA doubling time less than or equal to 10.0 months
Exclusion
- 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 intravenous bisphosphonate administration
Key Trial Info
Start Date :
January 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2014
Estimated Enrollment :
1435 Patients enrolled
Trial Details
Trial ID
NCT00286091
Start Date
January 24 2006
End Date
April 9 2014
Last Update
October 17 2018
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