Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists

Rabin Medical Center80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms Cardiovascular Diseases

Interventions

Degarelix (LHRH antagonist)DRUG

Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.

LHRH agonistDRUG

LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

EndoPAT2000DEVICE

Peripheral arterial plethysmography using an EndoPAT2000 device

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (2)

Rambam Health Care Campus

Haifa, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

Outcomes

Primary Outcomes

Change in Reactive Hyperemia Index from baseline to twelve months

the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000

Time frame: Baseline, and twelve months

Secondary Outcomes

Change in High sensitivity troponin (hsTn) value

High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury

Time frame: Baseline, and after three, six and twelve months of treatment initiation

Change in C-reactive protein value

C-reactive protein is a biomarker for inflammation

Time frame: Baseline, and after three, six and twelve months of treatment initiation

Change in D-dimer value

D-dimer is a biomarker for coagulation system activation

Time frame: Baseline, and after three, six and twelve months of treatment initiation

Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value

N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain

Time frame: Baseline, and after three, six and twelve months of treatment initiation

Data from ClinicalTrials.gov

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