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

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ClinicalTrials.gov Identifier: NCT02475057
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Cardiovascular Diseases Drug: Degarelix (LHRH antagonist) Drug: LHRH agonist Device: EndoPAT2000 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Degarelix (LHRH antagonist)
Degarelix (LHRH antagonist) EndoPAT2000
Drug: Degarelix (LHRH antagonist)
Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
Other Name: Firmagon

Device: EndoPAT2000
Peripheral arterial plethysmography using an EndoPAT2000 device
Other Name: Peripheral arterial plethysmography

Active Comparator: LHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000
Drug: LHRH agonist
LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
Other Name: Luteinizing hormone-releasing hormone agonist

Device: EndoPAT2000
Peripheral arterial plethysmography using an EndoPAT2000 device
Other Name: Peripheral arterial plethysmography




Primary Outcome Measures :
  1. Change in Reactive Hyperemia Index from baseline to twelve months [ Time Frame: Baseline, and twelve months ]
    the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000


Secondary Outcome Measures :
  1. Change in High sensitivity troponin (hsTn) value [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury

  2. Change in C-reactive protein value [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    C-reactive protein is a biomarker for inflammation

  3. Change in D-dimer value [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    D-dimer is a biomarker for coagulation system activation

  4. Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain


Other Outcome Measures:
  1. Change in testosterone level [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
  2. Change in gonadotropins levels [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    LH

  3. Change in PSA value [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    Prostate-specific antigen

  4. Change in BMI [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    Body Mass Index

  5. Change in Quality Of Life score [ Time Frame: Baseline, and after three, six and twelve months of treatment initiation ]
    As assessed by the FACT-P quality of life questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475057


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel, 4941492
Sponsors and Collaborators
Rabin Medical Center
Ferring Pharmaceuticals
Investigators
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Principal Investigator: David Margel, MD, PhD Rabin Medical Center

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02475057    
Other Study ID Numbers: 0102-15-RMC
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rabin Medical Center:
Prostate Cancer
Cardiovascular disease
Degarelix
Additional relevant MeSH terms:
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Prostatic Neoplasms
Cardiovascular Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prolactin Release-Inhibiting Factors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs