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

Phase 4

Completed

• Conditions: Cardiovascular Diseases; Prostatic Neoplasms
• Interventions: Drug: Degarelix (LHRH antagonist); Drug: LHRH agonist; Device: EndoPAT2000

• Registration Number: NCT02475057
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-18
• Study Start: 2015-08
• Primary Completion: 2018-07
• Status Verified: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix (LHRH antagonist)	Degarelix (LHRH antagonist)	Degarelix (LHRH antagonist) EndoPAT2000
LHRH agonist	LHRH agonist	LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
Degarelix (LHRH antagonist)	EndoPAT2000	Degarelix (LHRH antagonist) EndoPAT2000
LHRH agonist	EndoPAT2000	LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (2)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Rabin Medical Center - Beilinson Hospital; 🇮🇱 Petah Tikva, Israel