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Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

NCT01824342 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-03-05

Study results available
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Summary

This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.

Conditions

  • Castrate-resistant Prostate Cancer

Interventions

BIOLOGICAL

Denosumab

Administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Czechia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824342 on ClinicalTrials.gov