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

This study is ongoing, but not recruiting participants.

First Received on February 2, 2006. Last Updated on June 2, 2011 History of Changes

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00286091

Purpose

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.

Condition	Intervention	Phase
Hormone Refractory Prostate Cancer	Biological: denosumab Biological: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

Further study details as provided by Amgen:

Enrollment:	1435
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2014
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: denosumab 120 mg, SC Q4W
Placebo Comparator: 2	Biological: Placebo same volume Other Name: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286091

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Nov 15.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00286091 History of Changes
Other Study ID Numbers:	20050147
Study First Received:	February 2, 2006
Last Updated:	June 2, 2011
Health Authority:	Australia: Therapeutic Goods Administration; Canada: Health Canada; EU: EMEA; United States: Food and Drug Administration

Keywords provided by Amgen:

Hormone refractory prostate cancer
androgen independent
ADT
bone metastasis

Additional relevant MeSH terms:

Neoplasm Metastasis
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012