A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design

What Was Tested

The paper reports a study of Leuprolide, published as a clinical study.

Limited data from controlled clinical trials are available for men who experience biochemical recurrence after definitive therapy for prostate cancer.

In the absence of overt metastases, patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) often receive androgen deprivation therapy (ADT).

Who Took Part

PubMed tags the participants as men only.

EMBARK is a randomised, phase 3 study of high-risk patients with nmCSPC, a PSADT of ≤9 months and a screening PSA of ≥2 ng/mL above the nadir after radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) with or without postoperative RT.

Treatment is suspended at week 37 if PSA concentrations are <0.2 ng/mL and reinstated if levels rise to ≥2.0 ng/mL with RP or ≥5.0 ng/mL without RP.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label and placebo-controlled study.

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

Neither the participants nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

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.

A placebo (an inactive look-alike) gave the Leuprolide group a baseline to be compared against.

Patients with PSA ≥0.2 ng/mL at week 37 continue until treatment discontinuation criteria are met.

The primary endpoint is MFS comparing enzalutamide plus LHRHa versus placebo plus LHRHa.

What Was Measured

There is no standard-of-care consensus on optimal ADT timing, although most men are treated prior to metastases, especially those with high-risk features (Gleason score 8-10 or prostate-specific antigen doubling time (PSADT) <9-12 months).

The subject headings attached to it are Androgen Antagonists, Benzamides, Leuprolide, Neoplasm Recurrence, Local, Nitriles, Phenylthiohydantoin and Prostate-Specific Antigen.

Author keywords: clinical trials, genitourinary medicine and prostate disease.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Leuprolide.

The publication is from 2021 (BMJ open), a journal based in England.

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