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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

Secondary outcome measures

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%

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

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

~2760

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,529 Total Patients Enrolled

14 Trials studying Prostate Cancer

3,028 Patients Enrolled for Prostate Cancer

Elizabeth Kessler, MDPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Prostate Cancer

30 Patients Enrolled for Prostate Cancer

Media Library

Degarelix (LHRH Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02278185 — Phase 2

Prostate Cancer Research Study Groups: Arm II (ADT), Arm I (enzalutamide)

Prostate Cancer Clinical Trial 2023: Degarelix Highlights & Side Effects. Trial Name: NCT02278185 — Phase 2

Degarelix (LHRH Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02278185 — Phase 2

Frequently Asked Questions

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

What experiments have been conducted to study the efficacy of Enzalutamide?

"Currently, there are 218 clinical studies involving enzalutamide, with a substantial 70 of them in phase 3. The bulk of these trials take place in Lincoln, Nebraska though across the globe there are still 1335 centres running this medication trial."

Answered by AI

Are there any vacancies remaining for volunteers in this clinical experiment?

"Unfortunately, this trial has concluded its recruitment process. The study was first advertised on November 11th 2015 and had the latest edit made to it on April 26th 2022. However, for those seeking alternatives there are currently 1259 active trials recruiting patients with recurrent prostate cancer and 218 studies actively enrolling participants in Enzalutamide research."

Answered by AI

Is this experiment an unprecedented event in the medical realm?

"Currently, 218 active trials for Enzalutamide are being conducted across the world; from 2117 cities in 59 nations. The initial clinical trial was initiated by AstraZeneca back in 2000 and involved 600 patients who completed Phase 3 drug approval stage. Since then, 405 trials have concluded their studies."

Answered by AI

Is Enzalutamide a secure treatment option for people?

"As a Phase 2 trial, with evidence only of safety and none for efficacy, our team at Power ranked Enzalutamide's risk as a 2."

Answered by AI

For what medical treatments is Enzalutamide typically prescribed?

"Enzalutamide is often employed to treat diseases confirmed by clinical diagnosis, as well as kidney failure, carcinoma and fibroid tumors."

Answered by AI

How many individuals are enrolled in the experiment at this time?

"This research is no longer seeking participants. It was posted on 11/11/2015 and its final update occurred on 4/26/2022. If you are looking for alternate trials, 1259 studies that investigate recurrent prostate cancer and 218 investigations of Enzalutamide are actively recruiting volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer

2015. "Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02278185.

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