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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Ferring Pharmaceuticals
• Treatments: Hormones; Prolactin Release-Inhibiting Factors

Criteria

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.