Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
Hormone Refractory Prostate Cancer
About this trial
This is an interventional prevention trial for Hormone Refractory Prostate Cancer focused on measuring Hormone refractory prostate cancer, androgen independent, ADT, bone metastasis
Eligibility Criteria
Inclusion Criteria: 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 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 intravenous bisphosphonate administration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Denosumb
Participants received placebo subcutaneous injections every 4 weeks during the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injection every 4 weeks during the open-label extension phase.
Participants received 120 mg denosumab administered by subcutaneous injection every 4 weeks during the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injection every 4 weeks during the open-label extension phase.