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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475057
• Other study ID #: 0102-15-RMC
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix (LHRH antagonist)
Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
• LHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

Device:
• EndoPAT2000
Peripheral arterial plethysmography using an EndoPAT2000 device

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin Medical Center - Beilinson Hospital	Petah Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Ferring Pharmaceuticals

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in testosterone level		Baseline, and after three, six and twelve months of treatment initiation
Other	Change in gonadotropins levels	LH	Baseline, and after three, six and twelve months of treatment initiation
Other	Change in PSA value	Prostate-specific antigen	Baseline, and after three, six and twelve months of treatment initiation
Other	Change in BMI	Body Mass Index	Baseline, and after three, six and twelve months of treatment initiation
Other	Change in Quality Of Life score	As assessed by the FACT-P quality of life questionnaire	Baseline, and after three, six and twelve months of treatment initiation
Primary	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	Baseline, and twelve months
Secondary	Change in High sensitivity troponin (hsTn) value	High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury	Baseline, and after three, six and twelve months of treatment initiation
Secondary	Change in C-reactive protein value	C-reactive protein is a biomarker for inflammation	Baseline, and after three, six and twelve months of treatment initiation
Secondary	Change in D-dimer value	D-dimer is a biomarker for coagulation system activation	Baseline, and after three, six and twelve months of treatment initiation
Secondary	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	Baseline, and after three, six and twelve months of treatment initiation