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Brief Title: 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
Official Title: 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
Study ID: NCT01933022
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Site NL31005 St. Antonius ziekenhuis, Nieuwegein, , Netherlands
Site NL31004 Radboudumc, Nijmegen, , Netherlands
Site NL31001 Canisius-Wilhelmina Ziekenhuis, Nijmegen, , Netherlands
Name: Clinical Study Manager
Affiliation: Astellas Pharma Europe Ltd.
Role: STUDY_CHAIR