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

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.

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Key information

Conditions

Cancer Carcinoma Castrate-Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostate Cancer Prostatic Diseases Prostatic Neoplasms Tumors Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denosumab

Drug

60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18

Primary outcomes

Overall Survival Through Month 24

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 6, 2009
Registry last updated: Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed