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

What Was Tested

The trial (phase 4) is built around Degarelix.

It had two arms (groups): Degarelix (LHRH antagonist) (experimental) and LHRH agonist (active comparator).

Degarelix (LHRH antagonist) EndoPAT2000.

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

The registry classes the interventions as device and drug.

More on the Plan

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).

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.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to men only aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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:. Ischaemic or Haemorrhagic cerebrovascular conditions. Arterial embolic and thrombotic events,.

The full record lists 12 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Degarelix study did not mask who received what.

It started in 2015-08 with completion listed for 2018-07.

It ran at 2 sites in Israel (2).

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Change in Reactive Hyperemia Index from baseline to twelve months (time frame: Baseline, and twelve months).

It also tracked 4 secondary outcomes, for example Change in High sensitivity troponin (hsTn) value, Change in C-reactive protein value, Change in D-dimer value and Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Degarelix in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, all human trials.