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

• Status: Completed
• Trial end date: 2012-05-03
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Androgens; Denosumab

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