Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
Phase 3
Completed
- Conditions
- Castrate-Resistant Prostate CancerCancerCarcinomaTumorsProstate Cancer
- Interventions
- Registration Number
- NCT00838201
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 384
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Denosumab -
- Primary Outcome Measures
Name Time Method Overall Survival Through Month 24 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇵🇱Wroclaw, Poland