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Antiandrogen

Enzalutamide + Leuprolide for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer

Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

Awards & highlights

Study Summary

This trial will test whether adding the drug enzalutamide to leuprolide helps patients with high-risk prostate cancer that has come back after surgery or radiotherapy.

Who is the study for?

Men with high-risk, nonmetastatic prostate cancer that's progressing after surgery or radiation can join. They need a PSA doubling time of ≤9 months and certain PSA levels depending on prior treatments. Exclusions include recent use of specific drugs, brain metastasis, distant metastases, previous hormonal therapy (with some exceptions), chemotherapy for prostate cancer, major surgery within the last month, or another invasive cancer in the past 3 years.Check my eligibility

What is being tested?

The study is testing enzalutamide combined with leuprolide against prostate cancer that hasn't spread elsewhere in the body. The trial was initially randomized and blinded but now continues as an open-label study where everyone receives the actual treatment without any placebo.See study design

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain and hot flushes. Leuprolide might lead to reactions at injection site, hot flashes, testicular shrinkage and could increase risk for diabetes and heart disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA level is above 1 ng/mL after prostate surgery or 2 ng/mL above the lowest point after radiotherapy.

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My prostate cancer was initially treated with surgery or radiation aimed at curing it.

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My prostate cancer was confirmed by a biopsy and does not have certain aggressive features.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023

Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023

+19 more

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582

34%

Fatigue

25%

Decreased appetite

18%

Asthenia

17%

Back pain

16%

Arthralgia

15%

Nausea

13%

Bone pain

13%

Diarrhoea

13%

Constipation

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Dizziness

Haematuria

Insomnia

Hot flush

Malignant neoplasm progression

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pneumonia

Pulmonary embolism

Cardiac failure

Pyrexia

Urinary tract infection

Lower respiratory tract infection

Neutropenia

Metastases to central nervous system

Lung disorder

Renal failure

Osteoarthritis

100%

80%

60%

40%

20%

Study treatment Arm

Enzalutamide Total

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enzalutamide plus leuprolideExperimental Treatment2 Interventions

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks

Group II: Enzalutamide monotherapyExperimental Treatment1 Intervention

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Group III: Leuprolide plus placeboActive Control1 Intervention

Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,910,805 Total Patients Enrolled

41 Trials studying Prostate Cancer

11,301 Patients Enrolled for Prostate Cancer

Astellas Pharma IncIndustry Sponsor

690 Previous Clinical Trials

230,971 Total Patients Enrolled

35 Trials studying Prostate Cancer

7,574 Patients Enrolled for Prostate Cancer

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor

21 Previous Clinical Trials

8,865 Total Patients Enrolled

9 Trials studying Prostate Cancer

4,512 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02319837 — Phase 3

Prostate Cancer Research Study Groups: Enzalutamide plus leuprolide, Enzalutamide monotherapy, Leuprolide plus placebo

Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02319837 — Phase 3

Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02319837 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Enzalutamide most commonly employed?

"Enzalutamide is not only useful for treating advanced prostate cancer, but also for castration, anemia, and central precocious puberty (cpp)."

Answered by AI

Are there any harmful effects of Enzalutamide on patients?

"Enzalutamide has undergone Phase 3 clinical trials, meaning that there is both evidence of its efficacy and safety. Therefore, our team has rated it as a 3 on our safety scale."

Answered by AI

If so, could you provide more information on other research projects that have used Enzalutamide?

"Enzalutamide was first researched in 2004 by scientists at SUNY Downstate Medical Center. Since then, 18446 completed studies have been conducted on the drug. Now, there are 164 active clinical trials being done with many of them based in Rockville Centre, New york."

Answered by AI

Are we still receiving applicants for this research project?

"This study is not recruiting at this moment. The study was first made available on December 17th, 2014 and was last edited on August 29th, 2022. However, there are 1348 other clinical trials for prostate cancer and 164 for Enzalutamide that are looking for patients."

Answered by AI

How many people are being asked to join this clinical trial?

"This study has wrapped up its recruitment period. It was first announced on December 17th, 2014 and received its last update on August 29th, 2029. For individuals looking for other studies, there are 1,348 clinical trials enrolling patients with prostate cancer and 164 trials testing the efficacy of Enzalutamide."

Answered by AI

Recent research and studies

BMJ OpenJournal

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

Freedland, Stephen J, Ugo De Giorgi, Martin Gleave, Brad Rosbrook, Qi Shen, Jennifer Sugg, Gabriel P Haas, and Neal D Shore. 2021. “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”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-046588.

clinicaltrials.govStudy

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

2014. "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02319837.

All > Metastatic Prostate Cancer