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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 Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Honolulu, Hawaii  
Research Site Boise, Idaho  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ames, Iowa  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Branson, Missouri  
Research Site Billings, Montana  
Research Site Grand Island, Nebraska  
Research Site Las Vegas, Nevada  
Research Site Belleville, New Jersey  
Research Site Albuquerque, New Mexico  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Bismarck, North Dakota  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Charleston, South Carolina  
Research Site Aberdeen, South Dakota  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington