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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838201
• Other study ID #: 20080537
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2009
• Est. completion date: May 3, 2012

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: May 3, 2012
• Est. primary completion date: May 3, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Carcinoma
• Castrate-Resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Tumors

Intervention

Drug:
• Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Locations

Country	Name	City	State
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Brantford	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	Guelph	Ontario
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	North Bay	Ontario
Canada	Research Site	North York	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Victoria	British Columbia
Finland	Research Site	Seinajoki
Finland	Research Site	Tampere
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Nyiregyhaza
Mexico	Research Site	Mexico City	Distrito F
Mexico	Research Site	Mexico City	Distrito F
Mexico	Research Site	Toluca
Mexico	Research Site	Veracruz
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Opole
Poland	Research Site	Siedlce
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
United States	Research Site	Albany	New York
United States	Research Site	Anaheim	California
United States	Research Site	Bay Shore	New York
United States	Research Site	Burien	Washington
United States	Research Site	Dallas	Texas
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Garden City	New York
United States	Research Site	Greenbelt	Maryland
United States	Research Site	Huntsville	Alabama
United States	Research Site	Laguna Hills	California
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Long Beach	California
United States	Research Site	Middlebury	Connecticut
United States	Research Site	Myrtle Beach	South Carolina
United States	Research Site	New Britain	Connecticut
United States	Research Site	Omaha	Nebraska
United States	Research Site	Poughkeepsie	New York
United States	Research Site	Salem	Virginia
United States	Research Site	San Bernardino	California
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	Santa Monica	California
United States	Research Site	Sartell	Minnesota
United States	Research Site	Seattle	Washington
United States	Research Site	Tacoma	Washington
United States	Research Site	Trinity	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Hungary,  Mexico,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Through Month 24		24 months

External Links

•   AmgenTrials clinical trials website