Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rabin Medical Center
With
Ferring Pharmaceuticals
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.
Age
18–90
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
Scheduled to start ADT for a period of at least one year.
Subject has a history of one or more of the following:
1. Myocardial infarction
2. Ischaemic or Haemorrhagic cerebrovascular conditions
3. Arterial embolic and thrombotic events,
4. Ischaemic heart disease
5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)