Active not recruitingPHASE3INTERVENTIONAL

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

The EMBARK study is exploring a new treatment approach for men with high-risk prostate cancer that hasn't spread to other parts of the body. These men have already had surgery or radiotherapy for their prostate cancer. Researchers are testing a combination of two drugs, enzalutamide and leuprolide, to see if it's safe and helps keep the cancer in check. Initially, some participants received a placebo, but that part of the study has finished. The study is now continuing, with all participants receiving the active drugs openly. The aim is to understand how well this treatment works and if it can improve outcomes for these patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

1,068

Start

17 Dec 2014

Estimated completion

19 Sep 2026

Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate

Results

Results from this study

Posted March 2024

Results have been published for this study.

Primary outcome

Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide

MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.

Full results on the registry

What is this study about?

This study, called EMBARK, is looking into a new way to treat prostate cancer that is considered 'high-risk' but hasn't yet spread to other parts of the body. Men in this study have already undergone standard treatments like surgery to remove the prostate or radiotherapy. Even after these treatments, some men might have a rising level of a protein called PSA in their blood, which suggests the cancer might be becoming more active.

The main aim of this study is to see if combining two medicines, enzalutamide and leuprolide, can effectively manage this type of prostate cancer. Enzalutamide works by blocking certain hormones that prostate cancer needs to grow, while leuprolide is a type of hormone treatment that lowers testosterone levels. By using both together, researchers hope to achieve a stronger effect against the cancer.

Understanding how these two drugs work together is important because it could lead to new or improved treatment options for men whose prostate cancer might be progressing even after initial treatments. The research team wants to find out if this combination is safe for patients and if it can help slow down or stop the cancer from getting worse.

Key takeaways

It's a study for men with high-risk prostate cancer that hasn't spread.
It tests a combination of two existing prostate cancer drugs.
The goal is to see if this combination is safe and effective.
The study currently involves all participants receiving the active drugs.
Regular health checks are part of being in the study.

Who may be eligible?

To join this study, you would need to be a man with prostate cancer that has been confirmed by a doctor and hasn't spread to other parts of your body. You should have already had surgery or radiotherapy, or both, for your prostate cancer, with the aim to cure it. Your PSA levels would need to be showing signs of increasing, and your testosterone levels would need to be at a certain level.

However, you wouldn't be able to join if your cancer has already spread to distant parts of your body. Also, if you've already received certain hormone treatments, chemotherapy, or other specific cancer drugs, you might not be eligible. There are also restrictions if you've recently had major surgery or if you have a history of other specific cancers or brain metastases. The study is for men aged 18 and older.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I a man with confirmed prostate cancer?
Has my prostate cancer not spread to other parts of my body?
Have I already had surgery or radiotherapy for my prostate cancer?
Is my PSA level showing signs of increasing?
Have I avoided certain prior cancer treatments or major surgeries recently?

Answer every question to see your result.

What does participation involve?

This study started with a "randomized and blinded" phase, meaning some men received the study drugs and others received a dummy treatment (placebo), and neither you nor your doctor knew which you were getting. That part is now finished. The study is continuing in an "open-label" format, which means all participants are now receiving the study drugs (enzalutamide and leuprolide), and everyone knows what they are taking. You would regularly attend clinic visits where you would have blood tests, physical exams, and other tests to check your health and how the treatment is working. The total duration of your participation would depend on your individual response to the treatment, with ongoing follow-up to monitor your condition.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by giving you access to a new treatment combination that could help manage your high-risk prostate cancer. However, as with all medicines, there could be side effects from enzalutamide and leuprolide, although these would be carefully monitored by the study team. You would receive regular medical check-ups throughout the study. It’s important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (255)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
University of Alabama at Birmingham
Verified postcode
Birmingham, United States
University of Alabama at Birmingham, IDS Pharmacy
Verified postcode
Birmingham, United States
Alaska Urological Institute dba Alaska Clinical Research Center
Verified postcode
Anchorage, United States
Arizona Urology Specialists
Verified postcode
Tucson, United States
Tower Hematology Oncology Medical Group
Verified postcode
Beverly Hills, United States
Cedars-Senai OCC Pharmacy
Verified postcode
Los Angeles, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Verified postcode
Los Angeles, United States
University of California, Irvine Medical Center
Verified postcode
Orange, United States
Sutter Medical Group, Vascular & Varicose Vein Center
Verified postcode
Roseville, United States
Sutter Medical Group
Verified postcode
Roseville, United States
UC Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States

Common questions

What kind of prostate cancer is this study for?

This study is for men with high-risk prostate cancer that hasn't spread to other parts of the body, even after initial treatments like surgery or radiotherapy.

What are enzalutamide and leuprolide?

They are both medicines used to treat prostate cancer. Enzalutamide blocks hormones the cancer needs, and leuprolide lowers testosterone levels in your body.

Will I get a dummy treatment (placebo)?

No, the placebo part of the study has finished. All new and ongoing participants in the current phase are receiving the active study medicines.

How long would I be in the study?

The length of your participation would depend on your individual response to the treatment and generally involves ongoing follow-up.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time without having to give a reason, and it won't affect your future medical care.