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

NCT ID: NCT02475057

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-06-30

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.

Conditions

Prostatic Neoplasms; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Degarelix (LHRH antagonist)

Degarelix (LHRH antagonist) EndoPAT2000

Group Type: EXPERIMENTAL

Degarelix (LHRH antagonist)

Intervention Type: DRUG

Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.

EndoPAT2000

Intervention Type: DEVICE

Peripheral arterial plethysmography using an EndoPAT2000 device

LHRH agonist

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

Group Type: ACTIVE_COMPARATOR

LHRH agonist

Intervention Type: DRUG

LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

EndoPAT2000

Intervention Type: DEVICE

Peripheral arterial plethysmography using an EndoPAT2000 device

Interventions

Degarelix (LHRH antagonist)

Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.

Intervention Type: DRUG

LHRH agonist

LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

Intervention Type: DRUG

EndoPAT2000

Peripheral arterial plethysmography using an EndoPAT2000 device

Intervention Type: DEVICE

Other Intervention Names

Firmagon; Luteinizing hormone-releasing hormone agonist; Peripheral arterial plethysmography

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Margel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rambam Health Care Campus

Haifa, , Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Countries

Israel

References

Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

Reference Type: DERIVED

PMID: 34350976 (View on PubMed)

Other Identifiers

0102-15-RMC

Identifier Type: -

Identifier Source: org_study_id