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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which denosumab inhibits RANKL signaling in prostate cancer bone loss?
How does denosumab compare to bisphosphonates in managing bone loss during androgen-deprivation therapy for non-metastatic prostate cancer?
Which biomarkers correlate with long-term safety and efficacy of denosumab in castrate-resistant prostate cancer patients?
What are the most common adverse events associated with extended denosumab treatment in NCT00838201 and how are they managed?
Are there combination therapies involving denosumab that improve bone preservation in prostate cancer patients undergoing ADT?
Trial Locations
- Locations (1)
Research Site
🇵🇱Wroclaw, Poland
Research Site🇵🇱Wroclaw, Poland