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

Completed · Phase 3

Conditions studied: Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors

In brief

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.

Key facts

Study ID

NCT00838201

Run by

Amgen

People needed

384

Starts

2009-02-01

Expected to finish

2012-05-03

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be currently participating in the 20040138 Amgen study
• Subjects must sign the informed consent before any study specific procedures are performed.

You may not qualify if…

• 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

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Laguna Hills, California, United States
• Research Site — Long Beach, California, United States
• Research Site — San Bernardino, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Middlebury, Connecticut, United States
• Research Site — New Britain, Connecticut, United States
• Research Site — Trinity, Florida, United States
• Research Site — Fort Wayne, Indiana, United States
• Research Site — Greenbelt, Maryland, United States
• Research Site — Sartell, Minnesota, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Albany, New York, United States
• Research Site — Bay Shore, New York, United States
• Research Site — Garden City, New York, United States
• Research Site — Poughkeepsie, New York, United States
• Research Site — Lancaster, Pennsylvania, United States
• Research Site — East Providence, Rhode Island, United States
• Research Site — Myrtle Beach, South Carolina, United States
• Research Site — Dallas, Texas, United States
• Research Site — Salem, Virginia, United States
• Research Site — Burien, Washington, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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