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 Cancer; Cancer; Carcinoma; Tumors; Prostate Cancer
• Interventions: Drug: Denosumab

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02-01
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2012-05-03
• Study Completion: 2012-05-03
• Results First Submitted: 2013-07-23
• Results First Submitted QC: 2013-07-23
• Results First Posted: 2013-09-24
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

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

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Exclusion Criteria

Not provided

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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

Trial Locations

Locations (1)

Research Site; 🇵🇱 Wroclaw, Poland