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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00286091
First received: February 2, 2006
Last updated: August 2, 2013
Last verified: August 2013

February 2, 2006
August 2, 2013
February 2006
July 2010   (final data collection date for primary outcome measure)
Time to first occurance of bone metastasis or death from any cause [ Time Frame: 27 ] [ Designated as safety issue: No ]
Time to first occurance of bone metastasis or death from any cause
Complete list of historical versions of study NCT00286091 on ClinicalTrials.gov Archive Site
Not Provided
Time to first occurance of bone metastasis (excluding death). Overall survival.
Not Provided
Not Provided
 
Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hormone Refractory Prostate Cancer
  • Biological: denosumab
    120 mg, SC Q4W
  • Biological: Placebo
    same volume
    Other Name: Placebo
  • Experimental: 1
    Intervention: Biological: denosumab
  • Placebo Comparator: 2
    Intervention: Biological: Placebo
Smith MR, Saad F, Coleman R, Shore N, Fizazi K, Tombal B, Miller K, Sieber P, Karsh L, Damião R, Tammela TL, Egerdie B, Van Poppel H, Chin J, Morote J, Gómez-Veiga F, Borkowski T, Ye Z, Kupic A, Dansey R, Goessl C. Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial. Lancet. 2012 Jan 7;379(9810):39-46. doi: 10.1016/S0140-6736(11)61226-9. Epub 2011 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1435
February 2014
July 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00286091
20050147
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP