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A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Bone Metastases

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Trial Information

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer


Inclusion Criteria:



- Men >/= 18 years of age with histologically confirmed prostate cancer

- Radiographic evidence of at least one bone metastasis

- Failure of at least one hormonal therapy as evidenced by a rising PSA

- Serum testosterone level of <50 ng/dL

- ECOG PS 0, 1, or 2

- Adequate organ function

Exclusion Criteria:

- Current or prior IV bisphosphonate administration

- Current or prior oral bisphosphonates for bone mets

- Life expectancy of less than 6 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Time to the first on-study SRE (non-inferiority)

Outcome Time Frame:

Onset of event for 745 subjects

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Latvia: State Agency of Medicines

Study ID:

20050103

NCT ID:

NCT00321620

Start Date:

April 2006

Completion Date:

March 2012

Related Keywords:

  • Bone Metastases
  • Bone metastases
  • Hormone-refractory prostate cancer
  • Skeletal
  • Fractures
  • Compressions
  • Bisphosphonates
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteHonolulu, Hawaii  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteIvins, Utah  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington