Clinical Trials Directory

Trials / Terminated

TerminatedNCT01933022

A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease

An Exploratory, Open Label, Single-arm Study to Evaluate the Effect of Eligard® 6-month on Biomarkers of Disease in Patients With Metastatic Prostate Cancer

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Astellas Pharma Europe Ltd. · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate the effect of the study medication (Eligard®) on cancer markers (in the blood) of prostate cancer.

Detailed description

The main objective of the study is to explore the effect of Eligard® on the following prostate cancer biomarkers: Testosterone in serum, Prostate Specific Antigen (PSA) in serum, Prostate Cancer Antigen (PCA3 score) in urine, PSA mRNA in blood/Peripheral Blood Mononuclear Cell (PBMC), PCA3 mRNA in blood/PBMC, Transmembrane protease, serine 2-Ets Related Gene (TMPRSS2-ERG) mRNA in blood/PBMC A blood sample for RNA analysis will also be collected and stored for future investigation in patients giving specific informed consent.

Conditions

Interventions

TypeNameDescription
DRUGEligardSubcutaneous Injection

Timeline

Start date
2014-08-01
Primary completion
2015-08-01
Completion
2015-08-01
First posted
2013-08-30
Last updated
2017-03-09

Locations

3 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01933022. Inclusion in this directory is not an endorsement.