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

Clalit Health Services

Status and phase: Completed; Phase 4

Conditions: Prostatic Neoplasms; Cardiovascular Diseases

Treatments: Drug: LHRH agonist; Drug: Degarelix (LHRH antagonist); Device: EndoPAT2000

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02475057

0102-15-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Degarelix (LHRH antagonist)

Experimental group

Description:

Degarelix (LHRH antagonist) EndoPAT2000

Treatment:

Device: EndoPAT2000

Drug: Degarelix (LHRH antagonist)

LHRH agonist

Active Comparator group

Description:

LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000

Treatment:

Device: EndoPAT2000

Drug: LHRH agonist