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

Last updated: September 20, 2018
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT00286091
20050147
  • Ages > 18
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • men with histologically confirmed prostate cancer

  • bilateral orchiectomy at least 6 months before randomization or continuousandrogen-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 duringcontinuous 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 2weeks, 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 orequal to 8.0 ng/mL, obtained no more than 3 months before randomization OR PSAdoubling time less than or equal to 10.0 months

Exclusion

Exclusion Criteria:

  • prior or current evidence of radiographically detectable bone metastasis

  • known prior or current evidence of any metastatic involvement of distant organs (lymphnode metastases in any region is acceptable)

  • prior or current intravenous bisphosphonate administration

Study Design

Total Participants: 1435
Study Start date:
January 24, 2006
Estimated Completion Date:
April 09, 2014

Study Description

Participants were randomized to receive denosumab 120 mg or placebo every 4 weeks (Q4W) until approximately 660 participants developed bone metastasis or died and the primary efficacy and safety analyses were completed.

All participants undergoing scheduled assessments were offered open-label denosumab 120 mg subcutaneous (SC) until they either developed a bone metastasis, obtained access to commercially available product in this setting, or for up to 3 years, whichever came first. For participants who ended participation before the open-label extension (OLE) phase or withdrew from investigational product during the OLE phase, their survival data was to be collected every 6 months for up to 3 years after their last dose of investigational product.

Participants in the Czech Republic and United Kingdom were enrolled under a separate protocol for the OLE phase per Health Authority request, and are reported separately (Study 20080585; NCT01824342).