Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00286091
First received: February 2, 2006
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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 who have no bone metastasis at baseline.
| Condition | Intervention | Phase |
|---|---|---|
|
Hormone Refractory Prostate Cancer |
Biological: denosumab Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- subject incidence of treatment-emergent adverse events, immunogenicity, and safety laboratory parameters [ Time Frame: 4 weeks after the last dose of open label treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 1435 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | February 2014 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: denosumab
120 mg, SC Q4W
|
| Placebo Comparator: 2 |
Biological: Placebo
same volume
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- men with histologically confirmed prostate cancer
- bilateral orchiectomy at least 6 months before randomization or continuous ADT with a 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 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 IV bisphosphonate administration
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00286091 History of Changes |
| Other Study ID Numbers: | 20050147 |
| Study First Received: | February 2, 2006 |
| Last Updated: | May 6, 2013 |
| Health Authority: | Australia: Therapeutic Goods Administration Canada: Health Canada EU: EMEA United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Hormone refractory prostate cancer androgen independent ADT bone metastasis |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013