← Back to Search

LHRH Antagonist

Enzalutamide for Prostate Cancer

Phase 2

Waitlist Available

Led By Elizabeth Kessler, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Age > 18 years

Eastern Cooperative Oncology Group (ECOG) 0-2

Must not have

A history of androgen deprivation therapy; patients receiving hormonal therapy in the adjuvant and/or neoadjuvant setting must have discontinued therapy at least 6 months prior to day 1 of treatment AND have a serum testosterone level >= 50 ng/dL AND cannot have received more than 18 months of previous ADT

A history of orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a different hormone therapy, enzalutamide, can reduce the risk of developing metabolic syndrome in men with prostate cancer that has spread.

Who is the study for?

Men over 18 with advanced prostate cancer that has spread or isn't suitable for primary therapy. They must have a life expectancy over 12 months, be able to consent, and use two forms of birth control if with a partner who can bear children. Excluded are those with low testosterone or PSA levels, certain blood counts or vitamin deficiencies, recent corticosteroid use, heart issues, seizures, brain metastasis, gastrointestinal disorders affecting drug absorption.

What is being tested?

The trial is testing whether enzalutamide reduces the risk of metabolic syndrome compared to standard hormone therapies in men with prostate cancer. Metabolic syndrome includes changes in cholesterol levels, blood pressure, sugar levels in the blood and body weight.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation/diarrhea and hot flashes. It might also affect mood causing anxiety or depression and could lead to high blood pressure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 18 years.

Select...

I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I stopped hormone therapy for cancer at least 6 months ago and my testosterone is normal.

Select...

I have had surgery to remove one or both of my testicles.

Select...

I have not used hormone therapy for cancer in the last 3 months.

Select...

I have been taking a daily dose of 5 mg or more of corticosteroids for over a month in the last 3 months.

Select...

I have had serious heart issues or uncontrolled high blood pressure recently.

Select...

I have been treated with enzalutamide before.

Select...

I have brain metastasis or active leptomeningeal disease.

Select...

My testosterone level is below 50 ng/dL.

Select...

I have had seizures or conditions that could lead to seizures, including a stroke or significant brain injury.

Select...

I have active hepatitis C.

Select...

I have stomach or intestine problems that could affect medicine absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metabolic Syndrome Incidence, Summarized by the Number of Patients With at Least 3 of the 5 Pre-specified Criteria

Secondary study objectives

Change in Bone Density

Change in Bone Turnover Markers as Measured by N-telopeptide

Change in Bone Turnover Markers, as Measured by Bone-specific Alkaline Phosphatase

+9 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%

Constipation

13%

Diarrhoea

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Haematuria

Dizziness

Malignant neoplasm progression

Insomnia

Hot flush

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pulmonary embolism

Pneumonia

Pyrexia

Renal failure

Neutropenia

Cardiac failure

Lower respiratory tract infection

Osteoarthritis

Urinary tract infection

Metastases to central nervous system

Lung disorder

100%

80%

60%

40%

20%

Study treatment Arm

Enzalutamide Total

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (enzalutamide)Experimental Treatment1 Intervention

Patients receive enzalutamide PO QD for 12 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (ADT)Active Control5 Interventions

Patients receive standard of care ADT comprising one of the following at the discretion of the treating physician: leuprolide acetate, goserelin acetate, histrelin acetate, triptorelin, or degarelix SC or IM for 12 months in the absence of disease progression or unacceptable toxicity. Patients may also choose to undergo surgical castration as an alternative form of ADT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

0 / 13Eligibility criteria met