Phase 3
Completed N=384
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
Cancer · Carcinoma · Castrate-Resistant Prostate Cancer · Prostate Cancer
Source: ClinicalTrials.gov NCT00838201 ↗
Enrolled (actual)
384
Serious AEs
25.0%
Results posted
Sep 2013
Primary outcomePrimary: Overall Survival Through Month 24 — 174; 184 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Through Month 24 |
174; 184 | — |
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
Data sourced from ClinicalTrials.gov (NCT00838201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.