A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease

Plain-language guide to NCT02663908: phase 3 randomized trial of Leuprolide and Degarelix, 545 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02663908
Phase: phase 3
Status: terminated early
Start: 2016-04-19
Completion (planned or actual): 2021-03-29
Participants: 545 (actual)
Design: randomized, single-blind, treatment
Conditions studied: Prostate Cancer
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Leuprolide and Degarelix.

It had two arms (groups): Degarelix (experimental) and Leuprolide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 545 actual participants took part.

It was open to men only.

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

Examples of who could join: Indication to initiate androgen deprivation therapy (ADT). Predefined cardiovascular disease.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: acute cardiovascular disease in the previous 30 days.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

In this single-blind Leuprolide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-04-19 with completion listed for 2021-03-29.

It ran at 133 sites in United States (48), Slovakia (15), Germany (12), Canada (10), France (10) and Russia (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial (time frame: Randomization to Day 336 (end-of-trial)).

It also tracked 18 secondary outcomes, for example Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups, Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores, Total Number of CV-related Hospitalization Events Over the Duration of the Trial, Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial, Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) and Changes From Baseline in Duke Activity Status Index (DASI) Global Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide and Degarelix in 545 people.

With 545 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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

Our Notes on the Compounds

Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.

Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.