Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00838201
First received: February 5, 2009
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.


Condition Intervention Phase
Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors
Drug: Denosumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall Survival Through Month 24 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: February 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

  Eligibility

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

Inclusion Criteria:

  • Subjects must be currently participating in the 20040138 Amgen study
  • Subjects must sign the informed consent before any study specific procedures are performed.

Exclusion Criteria

  • Subjects with any prior diagnosis of bone metastasis
  • Known hypocalcemia
  • Developed sensitivity to mammalian cell derived drug products during the 20040138 study
  • Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838201

  Hide Study Locations
Locations
United States, Alabama
Research Site
Huntsville, Alabama, United States, 35801
United States, California
Research Site
Anaheim, California, United States, 92801
Research Site
Laguna Hills, California, United States, 92653
Research Site
Long Beach, California, United States, 90813
Research Site
San Bernardino, California, United States, 92404
Research Site
San Diego, California, United States, 92120
Research Site
San Diego, California, United States, 92103
Research Site
Santa Monica, California, United States, 90404
United States, Connecticut
Research Site
Middlebury, Connecticut, United States, 06762
Research Site
New Britain, Connecticut, United States, 06052
United States, Florida
Research Site
Trinity, Florida, United States, 34655
United States, Indiana
Research Site
Fort Wayne, Indiana, United States, 46825
United States, Maryland
Research Site
Greenbelt, Maryland, United States, 20770
United States, Minnesota
Research Site
Sartell, Minnesota, United States, 56377
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68114
United States, New York
Research Site
Albany, New York, United States, 12208
Research Site
Bay Shore, New York, United States, 11706
Research Site
Garden City, New York, United States, 11530
Research Site
Poughkeepsie, New York, United States, 12601
United States, Pennsylvania
Research Site
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Research Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Research Site
Dallas, Texas, United States, 75231
United States, Virginia
Research Site
Salem, Virginia, United States, 24153
United States, Washington
Research Site
Burien, Washington, United States, 98166
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Seattle, Washington, United States, 98104
Research Site
Tacoma, Washington, United States, 98405
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
Research Site
Kelowna, British Columbia, Canada, V1Y 2H4
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Surrey, British Columbia, Canada, V3V 1N1
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Vancouver, British Columbia, Canada, V5Z 1M9
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Victoria, British Columbia, Canada, V8T 5G1
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Victoria, British Columbia, Canada, V8V 3N1
Canada, Ontario
Research Site
Barrie, Ontario, Canada, L4M 7G1
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Brantford, Ontario, Canada, N3R 4N3
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Burlington, Ontario, Canada, L7S 1V2
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Burlington, Ontario, Canada, L7N 3V2
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Guelph, Ontario, Canada, N1H 5J1
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Kingston, Ontario, Canada, K7L 3J7
Research Site
Kitchener, Ontario, Canada, N2N 2B9
Research Site
London, Ontario, Canada, N6A 4G5
Research Site
Markham, Ontario, Canada, L6B 1A1
Research Site
Newmarket, Ontario, Canada, L3X 1W1
Research Site
North Bay, Ontario, Canada, P1B 7K8
Research Site
North York, Ontario, Canada, M2J 1V1
Research Site
Oakville, Ontario, Canada, L6H 3P1
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Oshawa, Ontario, Canada, L1H 7K4
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Scarborough, Ontario, Canada, M1P 2T7
Research Site
Sudbury, Ontario, Canada, P3E 4T3
Research Site
Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M2J 1V1
Research Site
Toronto, Ontario, Canada, M6A 3B5
Canada, Quebec
Research Site
Greenfield Park, Quebec, Canada, J4V 2H3
Research Site
Montreal, Quebec, Canada, H3G 1A4
Finland
Research Site
Seinajoki, Finland, 60220
Research Site
Tampere, Finland, 33520
Hungary
Research Site
Balatonfured, Hungary, 8230
Research Site
Budapest, Hungary, 1036
Research Site
Budapest, Hungary, 1204
Research Site
Gyor, Hungary, 9023
Research Site
Nyiregyhaza, Hungary, 4400
Mexico
Research Site
Mexico City, Distrito F, Mexico, 14140
Research Site
Mexico City, Distrito F, Mexico, 07760
Research Site
Toluca, Mexico, 50120
Research Site
Veracruz, Mexico, 91700
Poland
Research Site
Bialystok, Poland, 15-276
Research Site
Bydgoszcz, Poland, 85-171
Research Site
Lublin, Poland, 20-954
Research Site
Lublin, Poland, 20-718
Research Site
Opole, Poland, 45-086
Research Site
Siedlce, Poland, 08-110
Research Site
Warszawa, Poland, 00-416
Research Site
Warszawa, Poland, 02-781
Research Site
Wroclaw, Poland, 50-088
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00838201     History of Changes
Other Study ID Numbers: 20080537
Study First Received: February 5, 2009
Results First Received: July 23, 2013
Last Updated: November 1, 2013
Health Authority: Canada: Health Canada
Mexico: Ministry of Health
United States: Food and Drug Administration
Czech Republic: Státní ústav pro kontrolu léciv (SUKL)
Finland: Finnish Medicines Agency
Hungary: National Institute for Quality- and Organizational Development in Healthcare and Medicines / National Institute of Pharmacy Directorate
Netherlands: Centrale Commissie Mesgebonden Onderzoek (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic

Keywords provided by Amgen:
Androgen deprivation therapy for non-metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014