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Hormone Therapy

Radium-223 + Abiraterone for Prostate Cancer (ERA 223 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed adenocarcinoma of the prostate
Male subjects of age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment until 4 weeks after last study treatment, up to 65 months
Awards & highlights
Pivotal Trial

ERA 223 Trial Summary

This trial is testing if adding radium-223 dichloride to standard treatment can prolong life and delay specific events related to prostate cancer that has spread to the bone.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that has spread to the bones but not to other organs like lungs or liver, and who haven't had chemotherapy. They should have low testosterone from medical or surgical castration, be in good physical condition (ECOG PS score 0-1), and have mild or no symptoms. Men with brain metastases, spinal cord compression history without full recovery, small cell carcinoma of the prostate, large lymph node metastasis (>3cm), prior chemo treatments for CRPC, high-dose steroid needs, recent blood transfusions or opiate use for pain are excluded.Check my eligibility
What is being tested?
The study tests if adding radium-223 dichloride to standard treatment with abiraterone acetate improves survival and delays bone-related events like fractures or bone pain needing X-ray treatment in prostate cancer patients. Participants will either receive radium-223 plus abiraterone (and prednisone/prednisolone) or a placebo (normal saline) plus abiraterone.See study design
What are the potential side effects?
Possible side effects include nausea, diarrhea, vomiting from abiraterone; radium-223 may cause bone marrow suppression leading to anemia and increased bleeding risk. Both can potentially increase fatigue levels.

ERA 223 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer diagnosis was confirmed through a tissue examination.
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I am a man aged 18 or older.
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My prostate cancer has worsened, shown by rising PSA levels or changes in scans.
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I have at least two bone metastases and no cancer spread to my lungs, liver, brain, or other organs.
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My prostate cancer causes no or mild symptoms.
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My PSA levels increased after stopping hormone therapy for prostate cancer.
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My testosterone levels are below 50 ng/dL due to treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.

ERA 223 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until 4 weeks after last study treatment, up to 65 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment until 4 weeks after last study treatment, up to 65 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptomatic Skeletal Event Free Survival (SSE-FS)
Secondary outcome measures
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Number of Participants With Any Treatment-emergent Additional Primary Malignancies
Number of Participants With Post-treatment Adverse Events
+10 more

Side effects data

From 2017 Phase 3 trial • 181 Patients • NCT02741271
16%
Asthma
9%
Nasopharyngitis
7%
Pharyngitis
6%
Rhinitis
3%
Influenza
3%
Upper respiratory tract infection
1%
Epididymitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MF MDI 100 mcg BID
MF/F MDI 100/10 mcg BID

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

ERA 223 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Radium-223 dichloride + Abi/PredExperimental Treatment3 Interventions
Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met)
Group II: Placebo + Abi/PredPlacebo Group3 Interventions
Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~2020
Prednisone/Prednisolone
2022
Completed Phase 3
~600
Radium-223 dichloride (Xofigo, BAY88-8223)
2014
Completed Phase 3
~10290

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,221 Previous Clinical Trials
25,180,708 Total Patients Enrolled
38 Trials studying Prostate Cancer
25,426 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLCIndustry Sponsor
973 Previous Clinical Trials
6,383,018 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,133 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,927 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02043678 — Phase 3
Prostate Cancer Research Study Groups: Placebo + Abi/Pred, Radium-223 dichloride + Abi/Pred
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT02043678 — Phase 3
Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02043678 — Phase 3

Frequently Asked Questions

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

Are there any unfilled appointments for this research project?

"As of 10/11/2022, this clinical trial is no longer looking for candidates. The study was first posted on 3/30/2014. If you are interested in other trials, 1274 studies for prostate cancer and 437 for Prednisone/Prednisolone are still recruiting patients."

Answered by AI

Are there any serious safety concerns for patients who take Prednisone/Prednisolone?

"Prednisone/Prednisolone is considered safe according to our team's estimation. This is a phase 3 trial, which suggests that there is some data affirming its efficacy and that it has undergone multiple rounds of safety testing."

Answered by AI

How many people have been enrolled in this clinical trial thus far?

"Presently, this clinical trial is not enrolling new patients. It was originally posted on 3/30/2014, with the most recent edit on 10/11/2022. For individuals seeking other studies, there are 1274 clinical trials actively searching for patients with prostate cancer and 437 studies for Prednisone/Prednisolone admitting new participants."

Answered by AI

For what purpose do people most often take Prednisone/Prednisolone?

"Prednisone/Prednisolone is most commonly used to manage multiple sclerosis, but it has also been shown to help patients with conditions such as ulcerative colitis, varicella-zoster virus acute retinal necrosis, and brain tumors."

Answered by AI

Is this trial limited to one location or are there multiple sites in the city where it is taking place?

"Enrolment for this trial is currently open at 36 sites. These include locations in Detroit, Spokane and Montreal. To reduce travel burdens, patients are encouraged to select the clinical trial site closest to their location."

Answered by AI

Are there any other similar research projects to this one that use Prednisone/Prednisolone?

"437 clinical trials are currently underway to research the efficacy of Prednisone/Prednisolone. Of these, 124 are in Phase 3. Most of the clinical trials for Prednisone/Prednisolone are being conducted in Duarte, California, though there are 17935 total locations running trials for Prednisone/Prednisolone."

Answered by AI
Recent research and studies
~74 spots leftby Feb 2025