Cardiovascular Diseases, Prostatic Neoplasms
Conditions
Keywords
Prostate Cancer, Cardiovascular disease, Degarelix
Brief summary
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.
Detailed description
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.
Interventions
DRUGDegarelix (LHRH antagonist)
Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
DRUGLHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
DEVICEEndoPAT2000
Peripheral arterial plethysmography using an EndoPAT2000 device
Sponsors
Ferring Pharmaceuticals
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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) 6. Peripheral vascular disease (e.g. significant stenosis (ABPI\<0.9), claudication, prior vascular surgery/intervention) * Life expectancy of over 12 months. * WHO performance status of 0-2 * Subject is able and has agreed to sign a consent form.
Exclusion criteria
* Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed. * Prior use of dutasteride/finasteride in past 6 months * Known allergic reaction to Degarelix. * Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reactive Hyperemia Index from baseline to twelve months | Baseline, and twelve months | the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in High sensitivity troponin (hsTn) value | Baseline, and after three, six and twelve months of treatment initiation | High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury |
| Change in C-reactive protein value | Baseline, and after three, six and twelve months of treatment initiation | C-reactive protein is a biomarker for inflammation |
| Change in D-dimer value | Baseline, and after three, six and twelve months of treatment initiation | D-dimer is a biomarker for coagulation system activation |
| Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value | Baseline, and after three, six and twelve months of treatment initiation | N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in testosterone level | Baseline, and after three, six and twelve months of treatment initiation | — |
| Change in gonadotropins levels | Baseline, and after three, six and twelve months of treatment initiation | LH |
| Change in PSA value | Baseline, and after three, six and twelve months of treatment initiation | Prostate-specific antigen |
| Change in BMI | Baseline, and after three, six and twelve months of treatment initiation | Body Mass Index |
| Change in Quality Of Life score | Baseline, and after three, six and twelve months of treatment initiation | As assessed by the FACT-P quality of life questionnaire |
Countries
Israel
Outcome results
None listed