Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00286091
First received: February 2, 2006
Last updated: July 18, 2014
Last verified: July 2014
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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:
- Time to first occurance of bone metastasis or death from any cause [ Time Frame: 27 ] [ Designated as safety issue: No ]
| Enrollment: | 1435 |
| Study Start Date: | February 2006 |
| Study Completion Date: | June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286091
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286091
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00286091 History of Changes |
| Other Study ID Numbers: | 20050147 |
| Study First Received: | February 2, 2006 |
| Last Updated: | July 18, 2014 |
| 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:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms |
Neoplasms by Site Prostatic Diseases Urogenital Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015