Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

What Was Tested

This registered phase 3 trial tested Leuprolide.

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

The randomized / blinded portion of the study is now completed following primary endpoint analyses.

The study remains ongoing in open label format.

It had three arms (groups): Enzalutamide plus leuprolide (experimental), Enzalutamide monotherapy (experimental) and Leuprolide plus placebo (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1068 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;. Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;. PSA doubling time ≤ 9 months;.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: prior or present evidence of distant metastatic disease as assessed by radiographic imaging;; prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;; prior systemic biologic therapy, including immunotherapy, for prostate cancer;.

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 Leuprolide group and the comparison group should start out alike.

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

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-12-17 with completion listed for 2023-01-31.

It ran at 255 sites in United States (77), Australia (26), Italy (23), Canada (19), Spain (16) and France (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide.

It also tracked 22 secondary outcomes, for example Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide, Time to Prostate-specific Antigen (PSA) Progression, Time to First Use of New Antineoplastic Therapy, Overall Survival (OS), Time to Distant Metastasis and Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 1068 people.

With 1068 participants it is a large trial for this field.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

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