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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 46 months after first patient entry

Awards & highlights

PEACE III 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.Check my eligibility

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.See study design

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.

PEACE III Trial 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.

PEACE III Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 46 months after first patient entry

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

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

Primary outcome measures

radiological progression-free survival

Secondary outcome measures

First symptomatic skeletal event

Occurence of adverse events

Overall survival

+10 more

PEACE III 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

~2760

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Latin American Cooperative Oncology GroupOTHER

40 Previous Clinical Trials

15,218 Total Patients Enrolled

3 Trials studying Prostate Cancer

191 Patients Enrolled for Prostate Cancer

BayerIndustry Sponsor

2,237 Previous Clinical Trials

25,326,532 Total Patients Enrolled

38 Trials studying Prostate Cancer

25,473 Patients Enrolled for Prostate Cancer

Cancer Trials IrelandNETWORK

84 Previous Clinical Trials

25,188 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

Frequently Asked Questions

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

What other research has been conducted on Enzalutamide?

"Enzalutamide was first studied in Canada, at Rosemere Cancer Centre. Since the original study in 2005, there have been a total of 85 completed studies with 103 active studies. Many of these active trials are based out of Québec and Ontario."

Answered by AI

Are volunteers still needed for this clinical trial?

"Yes, this study is still open to new participants according to the latest update on clinicaltrials.gov from June 9th, 2022. The original posting date for the trial was October 1st, 2015."

Answered by AI

In how many different facilities is this research project being conducted?

"8 clinical study sites are currently operational. They are situated in Québec, Toronto and Saint John as well as 8 other locations. To cut down on travel time and expenses, please select the location nearest you."

Answered by AI

Has Enzalutamide undergone FDA approval processes?

"Enzalutamide falls into the category of being a Phase 3 trial drug, meaning that while there is data supporting its efficacy, multiple rounds of testing have also been conducted to show its safety. Accordingly, our team has given it a score of 3."

Answered by AI

How many people are enrolled in this experiment?

"The sponsor, Astellas Pharma Europe Ltd., requires 416 eligible patients to run this clinical trial from various locations including Chuq-Pavillon Hotel-Dieu De Quebec in Québec and University Health Network - Oci Princess Margaret Hospital in Toronto."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Radium 223 mCRPC-PEACE III

2015. "Phase III Radium 223 mCRPC-PEACE III". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02194842.

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