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Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00286091
First received: February 2, 2006
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: March 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hormone Refractory Prostate Cancer
Interventions: Biological: Denosumab
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible subjects were men ≥ 18 years old with histologically-confirmed, castrate-resistant prostate cancer who were chemically or surgically castrated. The first patient was enrolled into the study on 03 February 2006 and the last patient was enrolled on 23 July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to denosumab or placebo in the double-blind treatment phase. All participants undergoing scheduled assessments were offered open-label denosumab for up to 3 years in the open-label extension phase. Three enrolled patients were excluded from all datasets per ethics committee’s instructions due to eligibility violations.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
Denosumab Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment Phase
    Placebo   Denosumab
STARTED   716   716 
Received Treatment   709 [1]   716 
On Study at Primary Data Analysis Cutoff   164 [2]   174 [2] 
COMPLETED   132 [3]   123 [3] 
NOT COMPLETED   584   593 
Withdrawal by Subject                103                113 
Protocol-Specified Criteria                307                269 
Death                58                65 
Adverse Event                28                40 
Disease Progression                22                35 
Other                25                33 
Administrative Decision                20                21 
Noncompliance                8                8 
Lost to Follow-up                11                4 
Protocol Deviation                1                3 
Ineligibility Determined                1                2 
[1] 4 participants received ≥ 1 dose of denosumab in error
[2] Primary analysis cut-off date was 30 July 2010
[3] On study through blinded treatment cutoff date of 09 January 2011

Period 2:   Open-label Treatment Phase
    Placebo   Denosumab
STARTED   110 [1]   104 [1] 
Received Treatment   109   101 
COMPLETED   33 [2]   33 [2] 
NOT COMPLETED   77   71 
Physician Decision                24                21 
Adverse Event                5                16 
Other                11                11 
Withdrawal by Subject                14                10 
Death                10                7 
Disease Progression                9                3 
Noncompliance                3                1 
Lost to Follow-up                0                1 
Protocol-specified Criteria                1                0 
Missing End of Study Information                0                1 
[1] Participants in the Czech Republic and UK are reported separately (Study 20080585; NCT01824342)
[2] Completed 3 years of open-label treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
Denosumab Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
Total Total of all reporting groups

Baseline Measures
   Placebo   Denosumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 716   716   1432 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.2  (8.3)   73.2  (8.8)   73.2  (8.6) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   716   716   1432 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   604   606   1210 
Black or African American   35   41   76 
Hispanic or Latino   37   32   69 
Asian   18   17   35 
Japanese   2   0   2 
American Indian or Alaska Native   2   0   2 
Native Hawaiian or Other Pacific Islander   1   0   1 
Other   17   18   35 
Unknown   0   2   2 
Eastern Cooperative Oncology Group (ECOG)Pperformance Status [1] 
[Units: Participants]
     
Grade 0   514   505   1019 
Grade 1   199   210   409 
Grade 2   3   1   4 
Grade 3   0   0   0 
Grade 4   0   0   0 
[1] A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
Prostate-Specific Antigen (PSA) Doubling Time 
[Units: Participants]
     
≤ 10 months   580   574   1154 
> 10 months   136   142   278 
Prostate-Specific Antigen (PSA) ≥ 8.0 ng/mL 
[Units: Participants]
     
Yes   471   473   944 
No   245   243   488 
Prior Chemotherapy Regimens 
[Units: Participants]
     
Yes   54   63   117 
No   662   653   1315 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Bone Metastasis-free Survival   [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ]

2.  Secondary:   Time to First Bone Metastasis   [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ]

3.  Secondary:   Overall Survival   [ Time Frame: From the first dose of investigational product to the primary data cutoff date of 30 July 2010; median time on study was approximately 20 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00286091     History of Changes
Other Study ID Numbers: 20050147
Study First Received: February 2, 2006
Results First Received: March 25, 2015
Last Updated: May 20, 2015