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Hormone Therapy

Enzalutamide + Radium 223 for Metastatic Prostate Cancer (PEACE III Trial)

Phase 3
Waitlist Available
Led By Silke Gillessen, Prof
Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of prostate adenocarcinoma
Metastatic to bone with ≥ 4 bone metastases
Must not have
No known history of central nervous system metastases or leptomeningeal tumor spread
No intake of narcotic analgesia for bone pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 46 months after first patient entry
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if a combination of two drugs is better than just one of the drugs at slowing down the progression of cancer that has spread to the bones.

Who is the study for?
Men at least 18 years old with prostate cancer that has spread to the bones and are asymptomatic or mildly symptomatic. They must have stopped certain treatments like abiraterone four weeks prior, not had other specific cancer treatments, no seizures in the past year, and be able to comply with study requirements. Those with serious health issues or conditions affecting study participation are excluded.
What is being tested?
The trial is testing if combining enzalutamide (a hormone therapy) and Ra223 (a radioactive drug) improves survival without cancer progression compared to just enzalutamide alone in men whose prostate cancer has spread to their bones.
What are the potential side effects?
Possible side effects include blood count changes, gastrointestinal issues, potential allergic reactions to medication components, fatigue from anemia or radiation exposure, bone marrow suppression leading to increased infection risk, and cardiovascular complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer was confirmed through a tissue examination.
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My cancer has spread to my bones with 4 or more spots.
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I am currently on hormone therapy for cancer.
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I do not have any serious illnesses besides my current condition.
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My testosterone levels are below 50 ng/dL.
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I do not have serious heart problems.
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I have only been diagnosed with prostate cancer.
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I can carry out all my usual activities without help.
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My heart functions normally.
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My cancer has not spread to my brain or spinal cord.
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I have never had a seizure.
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My cancer has not spread to my internal organs.
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I have not had treatment with radioactive substances before.
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I will start taking a bone protecting agent as my treatment begins.
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I have not had extensive radiation therapy that treats half of my body.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has not spread to my brain or spinal cord.
Select...
I am not taking narcotic painkillers for bone pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~46 months after first patient entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and 46 months after first patient entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
radiological progression-free survival
Secondary study objectives
First symptomatic skeletal event
Occurence of adverse events
Overall survival
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enzalutamide and Ra223Experimental Treatment2 Interventions
Ra223 will be administered 55kBq/kg standard dose monthly for 6 months and given in combination with enzalutamide at a dose of 160 mg daily.
Group II: EnzalutamideActive Control1 Intervention
Enzalutamide will be given at a dose of 160 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~3820

Find a Location

Who is running the clinical trial?

Latin American Cooperative Oncology GroupOTHER
41 Previous Clinical Trials
15,245 Total Patients Enrolled
4 Trials studying Prostate Cancer
261 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,274 Previous Clinical Trials
25,531,935 Total Patients Enrolled
44 Trials studying Prostate Cancer
26,529 Patients Enrolled for Prostate Cancer
Cancer Trials IrelandNETWORK
84 Previous Clinical Trials
25,119 Total Patients Enrolled
8 Trials studying Prostate Cancer
3,367 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02194842 — Phase 3
Prostate Cancer Research Study Groups: Enzalutamide, Enzalutamide and Ra223
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02194842 — Phase 3
Enzalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02194842 — Phase 3
~44 spots leftby Nov 2025
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