LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer.

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The Journal of urology2 May 2023Cited by 24 (Europe PMC)

PMID37119051DOI10.1097/ju.0000000000003518PepBankPUB-37119051

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In high-risk recurrent prostate cancer, metastasis-free survival was lower with leuprolide alone than enzalutamide monotherapy (monotherapy HR 0.63; p=0.0049).
In plain wordsIn patients with high-risk recurrent prostate cancer, metastasis-free survival was lower with leuprolide alone than enzalutamide monotherapy.
Peptide
Leuprolide
Outcome
DecreaseMetastasis-free survival
Study
n = 713
Comparator
Enzalutamide monotherapy
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22.5 mg every 12 weeksAs given in this study (human).
Measurements
Monotherapy hazard ratio
0.63
versus placebo plus leuprolide
95% CI
0.46 to 0.87
monotherapy hazard ratio
P value
0.0049
monotherapy versus placebo plus leuprolide
Source sentences
Summary
After median follow-up of 60.7 months, per BICR, MFS for enza + LA (HR 0.42; 95% CI 0.30-0.61; p<0.0001) and enza mono (HR 0.63; 95% CI 0.46-0.87; p=0.0049) were statistically superior to pbo + LA.
4 context sentences(design, population, supporting numbers)
Summary · context
1068 pts were randomized into the study (enza + LA, n=355; pbo + LA, n=358; enza mono, n=355).
Summary · context
EMBARK is a randomized, phase 3 study of pts with BCR considered high-risk: PSA doubling time ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT.
Summary · context
Pts were randomized (1:1:1) to enza 160 mg/day + leuprolide acetate (LA) (double-blind), placebo (pbo) + LA (double-blind), or enza mono (open-label).
Summary · context
LA 22.5 mg was administered every 12 weeks.
Report a problemFND-3711905101
02HumanRandomized controlled trialEfficacy outcome
In high-risk recurrent prostate cancer, PSA progression risk was higher with leuprolide alone than enzalutamide monotherapy (monotherapy HR 0.33; p<0.0001).
In plain wordsIn patients with high-risk recurrent prostate cancer, PSA progression risk was higher with leuprolide alone than enzalutamide monotherapy.
Peptide
Leuprolide
Outcome
IncreasePSA progression risk
Study
n = 713
Comparator
Enzalutamide monotherapy
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22.5 mg every 12 weeksAs given in this study (human).
Measurements
Monotherapy hazard ratio
0.33
versus placebo plus leuprolide
95% CI
0.23 to 0.49
monotherapy hazard ratio
P value
< 0.0001
both comparisons
Source sentences
Summary
Statistically significant improvements were also observed in risk of PSA progression (enza + LA: HR 0.07; 95% CI, 0.03-0.14; enza mono: HR 0.33; 95% CI, 0.23-0.49; both p<0.0001) and time to first use of new antineoplastic therapy (enza + LA: HR 0.36; 95% CI, 0.26-0.49; enza mono: HR 0.54; 95% CI, 0…
4 context sentences(design, population, supporting numbers)
Summary · context
1068 pts were randomized into the study (enza + LA, n=355; pbo + LA, n=358; enza mono, n=355).
Summary · context
EMBARK is a randomized, phase 3 study of pts with BCR considered high-risk: PSA doubling time ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT.
Summary · context
Pts were randomized (1:1:1) to enza 160 mg/day + leuprolide acetate (LA) (double-blind), placebo (pbo) + LA (double-blind), or enza mono (open-label).
Summary · context
LA 22.5 mg was administered every 12 weeks.
Report a problemFND-3711905102
03HumanRandomized controlled trialEfficacy outcome
In high-risk recurrent prostate cancer, time to new antineoplastic therapy was shorter with leuprolide alone than enzalutamide monotherapy (monotherapy HR 0.54).
In plain wordsIn patients with high-risk recurrent prostate cancer, time to new antineoplastic therapy was shorter with leuprolide alone than enzalutamide monotherapy.
Peptide
Leuprolide
Outcome
DecreaseTime to new antineoplastic therapy
Study
n = 713
Comparator
Enzalutamide monotherapy
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
22.5 mg every 12 weeksAs given in this study (human).
Measurements
Monotherapy hazard ratio
0.54
versus placebo plus leuprolide
95% CI
0.41 to 0.71
monotherapy hazard ratio
P value
< 0.0001
both comparisons
Source sentences
Summary
Statistically significant improvements were also observed in risk of PSA progression (enza + LA: HR 0.07; 95% CI, 0.03-0.14; enza mono: HR 0.33; 95% CI, 0.23-0.49; both p<0.0001) and time to first use of new antineoplastic therapy (enza + LA: HR 0.36; 95% CI, 0.26-0.49; enza mono: HR 0.54; 95% CI, 0…
4 context sentences(design, population, supporting numbers)
Summary · context
1068 pts were randomized into the study (enza + LA, n=355; pbo + LA, n=358; enza mono, n=355).
Summary · context
EMBARK is a randomized, phase 3 study of pts with BCR considered high-risk: PSA doubling time ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT.
Summary · context
Pts were randomized (1:1:1) to enza 160 mg/day + leuprolide acetate (LA) (double-blind), placebo (pbo) + LA (double-blind), or enza mono (open-label).
Summary · context
LA 22.5 mg was administered every 12 weeks.
Report a problemFND-3711905103
04HumanRandomized controlled trialEfficacy outcome
In high-risk recurrent prostate cancer, interim overall survival trended lower with leuprolide control than with enzalutamide monotherapy (monotherapy HR 0.78; 95% CI 0.52-1.17; p=0.2304).
In plain wordsIn patients with high-risk recurrent prostate cancer, interim overall survival trended lower with leuprolide control than with enzalutamide monotherapy.
Peptide
Leuprolide
Outcome
DecreaseInterim overall survival
Study
n = 713
Comparator
Enzalutamide monotherapy
Analysis
Secondary
Outcome group
Mortality · Cancer
Studied dose
22.5 mg every 12 weeksAs given in this study (human).
Measurements
Monotherapy hazard ratio
0.78
versus placebo plus leuprolide
95% CI
0.52 to 1.17
monotherapy hazard ratio
P value
0.2304
monotherapy versus placebo plus leuprolide
Source sentences
Summary
Interim OS data trended in favor enza + LA (HR 0.59; 95% CI, 0.38-0.91; p=0.0153, did not cross interim efficacy boundary) and enza mono (HR 0.78; 95% CI, 0.52-1.17; p=0.2304).
4 context sentences(design, population, supporting numbers)
Summary · context
1068 pts were randomized into the study (enza + LA, n=355; pbo + LA, n=358; enza mono, n=355).
Summary · context
EMBARK is a randomized, phase 3 study of pts with BCR considered high-risk: PSA doubling time ≤9 months and PSA ≥2 ng/mL above nadir post-radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT.
Summary · context
Pts were randomized (1:1:1) to enza 160 mg/day + leuprolide acetate (LA) (double-blind), placebo (pbo) + LA (double-blind), or enza mono (open-label).
Summary · context
LA 22.5 mg was administered every 12 weeks.
Report a problemFND-3711905104

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 ongoing · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 3Results postedNCT02319837

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

Pfizern = 1,06817 Dec 2014 to est. 30 Jul 2027

Hormone Sensitive Prostate Cancer · Prostate Cancer · Cancer of the Prostate

Trial page ClinicalTrials.govUpdated 26 Oct 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Keywords

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