Clinical trial NCT02475057: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Neoplasms
Cardiovascular Diseases
Keywords: Prostate Cancer
Cardiovascular disease
Degarelix
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2015-06-18
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Reactive Hyperemia Index from baseline to twelve months
timeFrame: Baseline, and twelve months
Secondary outcomes:
measure: Change in High sensitivity troponin (hsTn) value
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in C-reactive protein value
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in D-dimer value
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
Other outcomes:
measure: Change in testosterone level
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in gonadotropins levels
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in PSA value
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in BMI
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
measure: Change in Quality Of Life score
timeFrame: Baseline, and after three, six and twelve months of treatment initiation
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center
name: David Margel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.