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

Recruiting in Palo Alto (17 mi)

+64 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Principal Investigator

Amgen

Eligibility 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.

Treatment Details

Interventions

Denosumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Denosumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Prolia for:

Treatment of osteoporosis in postmenopausal women at high risk for fracture
Treatment to increase bone mass in men with osteoporosis at high risk for fracture