Cardiovascular Events in GnRH Agonist vs. Antagonist

What Was Tested

The trial (phase 2) is built around Degarelix.

It had two arms (groups): Degarelix (experimental) and GnRH-agonist (active comparator).

GnRH Antagonist.

GnRH Agonist.

The registry classes the interventions as drug.

More on the Plan

Study population: Subjects with pre-existing cardiovascular risk with locally advanced or metastatic prostate cancer and scheduled to start ADT in combination with either second line hormonal or chemotherapy.

The researchers will exclude patients with use of ADT 6 months prior to randomization.

Control- GnRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

Study Time line- The intervention phase will be for one year.

Who Took Part

80 planned participants were the target.

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: Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients. Patients are scheduled to receive a combination of either. Primary ADT for 12 months + either chemotherapy with docetaxel OR. Primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide. Ischaemic or haemorrhagic cerebrovascular conditions.

The full record lists 16 inclusion and 3 exclusion criteria; among the exclusions: known allergic reaction to degarelix; any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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

The Degarelix group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Degarelix was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-01-17 with completion listed for 2023-01-17.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: time to first cardiovascular event (time frame: 1 year).

It also tracked 10 secondary outcomes, for example time to first MACCE event, cardiac echocardiography, Hormonal Profile, NTproBNP levels, Adverse events and PSA levles.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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