Cardiovascular Diseases Clinical Trial
Official title:
A Pilot Study on Endothelial Function and Cardiovascular Biomarkers in Prostate Cancer (PCa) Patients, With Pre-existing Cardiovascular Disease, Treated With Degarelix vs. Luteinizing Hormone-Releasing Hormone (LHRH) Agonists
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
This is a national multicenter randomized open-label superiority study of the use of
Degarelix compared to LHRH agonists among men with advanced prostate cancer and pre-existing
cardiovascular disease. Patients will be stratified based on baseline endothelial function
and presence prostate cancer metastasis.
Study population: Subjects with pre-existing cardiovascular disease with locally advanced or
metastatic prostate cancer and scheduled to start Androgen Deprivation Therapy (ADT).
Patients already on ADT will be excluded. subjects will receive either two initial loading
doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months or
an LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year. Follow-up
visits will occur every 3 months. A blood sample for Prostate-specific antigen (PSA), cardiac
biomarkers and rectal examination will be performed each visit. At baseline 6 and 12 months
EndoPAT2000 measurements will be taken.
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