CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,435 enrolled
Drug / intervention
Denosumab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed prostate cancer
  • ✓Castration achieved via bilateral orchiectomy ≥6 months prior OR continuous ADT with GnRH agonist/antagonist ≥6 months prior
  • ✓Testosterone suppressed to <50 ng/dL
  • ✓Hormone-refractory prostate cancer: 3 consecutive rising PSA values (PSA1 < PSA2 < PSA3) separated by ≥2 weeks, with PSA2 and PSA3 ≥1.0 ng/mL, during continuous ADT or post-orchiectomy
Key exclusion· 3
  • ✕Radiographically detectable bone metastasis
  • ✕Metastatic involvement of distant organs other than lymph nodes (lymph node metastases are acceptable)
  • ✕Prior or current intravenous bisphosphonate therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00286091
NCT00286091Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer

Amgen·interventional·Posted Feb 3, 2006·Updated Oct 17, 2018

In Brief

A Phase 3 clinical trial evaluating Denosumab and Placebo for Hormone Refractory Prostate Cancer. Completed, enrolled 1,435 participants.

Detailed Summary

The purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone Refractory Prostate Cancer
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2006
Enrollment StartJan 24, 2006
Primary CompletionJul 30, 2010
Study CompletionApr 9, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.4 years ago

Interventions

Denosumabbiological

Administered by subcutaneous injection

Placebobiological

Same volume subcutaneous injection