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

Primary Purpose

Prostatic Neoplasms, Cardiovascular Diseases

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Degarelix (LHRH antagonist)
LHRH agonist
EndoPAT2000
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostatic Neoplasms focused on measuring Prostate Cancer, Cardiovascular disease, Degarelix

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Rambam Health Care Campus
  • Rabin Medical Center - Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Degarelix (LHRH antagonist)

LHRH agonist

Arm Description

Degarelix (LHRH antagonist) EndoPAT2000

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

Outcomes

Primary Outcome Measures

Change in Reactive Hyperemia Index from baseline to twelve months
the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000

Secondary Outcome Measures

Change in High sensitivity troponin (hsTn) value
High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury
Change in C-reactive protein value
C-reactive protein is a biomarker for inflammation
Change in D-dimer value
D-dimer is a biomarker for coagulation system activation
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value
N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain

Full Information

First Posted
June 8, 2015
Last Updated
June 11, 2019
Sponsor
Rabin Medical Center
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02475057
Brief Title
Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Cardiovascular Diseases
Keywords
Prostate Cancer, Cardiovascular disease, Degarelix

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix (LHRH antagonist)
Arm Type
Experimental
Arm Description
Degarelix (LHRH antagonist) EndoPAT2000
Arm Title
LHRH agonist
Arm Type
Active Comparator
Arm Description
LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
Intervention Type
Drug
Intervention Name(s)
Degarelix (LHRH antagonist)
Other Intervention Name(s)
Firmagon
Intervention Description
Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
Intervention Type
Drug
Intervention Name(s)
LHRH agonist
Other Intervention Name(s)
Luteinizing hormone-releasing hormone agonist
Intervention Description
LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
Intervention Type
Device
Intervention Name(s)
EndoPAT2000
Other Intervention Name(s)
Peripheral arterial plethysmography
Intervention Description
Peripheral arterial plethysmography using an EndoPAT2000 device
Primary Outcome Measure Information:
Title
Change in Reactive Hyperemia Index from baseline to twelve months
Description
the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000
Time Frame
Baseline, and twelve months
Secondary Outcome Measure Information:
Title
Change in High sensitivity troponin (hsTn) value
Description
High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in C-reactive protein value
Description
C-reactive protein is a biomarker for inflammation
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in D-dimer value
Description
D-dimer is a biomarker for coagulation system activation
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value
Description
N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Other Pre-specified Outcome Measures:
Title
Change in testosterone level
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in gonadotropins levels
Description
LH
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in PSA value
Description
Prostate-specific antigen
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in BMI
Description
Body Mass Index
Time Frame
Baseline, and after three, six and twelve months of treatment initiation
Title
Change in Quality Of Life score
Description
As assessed by the FACT-P quality of life questionnaire
Time Frame
Baseline, and after three, six and twelve months of treatment initiation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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: Myocardial infarction Ischaemic or Haemorrhagic cerebrovascular conditions Arterial embolic and thrombotic events, Ischaemic heart disease Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Margel, MD, PhD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34350976
Citation
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.
Results Reference
derived

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

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