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

NCT02475057 | Completed Phase 4 DMC

• 1 other identifier: 0102-15-RMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostatic Neoplasms; Cardiovascular Diseases

Keywords

Prostate Cancer; Cardiovascular disease; Degarelix

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, and twelve months

Secondary Outcomes (4)

• Change in High sensitivity troponin (hsTn) value

  Baseline, and after three, six and twelve months of treatment initiation

• Change in C-reactive protein value

  Baseline, and after three, six and twelve months of treatment initiation

• Change in D-dimer value

  Baseline, and after three, six and twelve months of treatment initiation

• Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value

  Baseline, and after three, six and twelve months of treatment initiation

Other Outcomes (5)

• Change in testosterone level

  Baseline, and after three, six and twelve months of treatment initiation

• Change in gonadotropins levels

  Baseline, and after three, six and twelve months of treatment initiation

• Change in PSA value

  Baseline, and after three, six and twelve months of treatment initiation

Study Arms (2)

Degarelix (LHRH antagonist)

EXPERIMENTAL

Degarelix (LHRH antagonist) EndoPAT2000

Drug: Degarelix (LHRH antagonist); Device: EndoPAT2000

LHRH agonist

ACTIVE COMPARATOR

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

Drug: LHRH agonist; Device: EndoPAT2000

Interventions

Degarelix (LHRH antagonist) DRUG

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

Also known as: Firmagon

Degarelix (LHRH antagonist)

LHRH agonist DRUG

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

Also known as: Luteinizing hormone-releasing hormone agonist

LHRH agonist

EndoPAT2000 DEVICE

Peripheral arterial plethysmography using an EndoPAT2000 device

Also known as: Peripheral arterial plethysmography

Degarelix (LHRH antagonist); LHRH agonist

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (2)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4941492, Israel

Location

Related Publications (1)

• 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.

  PMID: 34350976 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Cardiovascular Diseases

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• David Margel, MD, PhD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 18, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

IL (2)