NCT02475057

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasms
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Degarelix (LHRH antagonist)	Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
DRUG	LHRH agonist	LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
DEVICE	EndoPAT2000	Peripheral arterial plethysmography using an EndoPAT2000 device

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-07-01
• Completion: 2019-06-01
• First posted: 2015-06-18
• Last updated: 2019-06-12

Locations

2 sites across 1 country: Israel