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

Amgen

Status and phase: Completed; Phase 3

Conditions: Tumors; Castrate-Resistant Prostate Cancer; Carcinoma; Cancer; Prostate Cancer

Treatments: Drug: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838201

20080537

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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384 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Denosumab