Clinical trial NCT00838201: Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors
Keywords: Androgen deprivation therapy for non-metastatic prostate cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 384
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Overall Survival Through Month 24
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: San Bernardino
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Middlebury
country: United States
facility: Research Site
state: Connecticut
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Trinity
country: United States
facility: Research Site
state: Florida
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Greenbelt
country: United States
facility: Research Site
state: Maryland
city: Sartell
country: United States
facility: Research Site
state: Minnesota
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Albany
country: United States
facility: Research Site
state: New York
city: Bay Shore
country: United States
facility: Research Site
state: New York
city: Garden City
country: United States
facility: Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Research Site
state: New York
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Research Site
state: South Carolina
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Salem
country: United States
facility: Research Site
state: Virginia
city: Burien
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Brantford
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: North Bay
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Seinajoki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito F
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito F
city: Toluca
country: Mexico
facility: Research Site
city: Veracruz
country: Mexico
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Siedlce
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: