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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

Prostate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

Asymptomatic or mildly symptomatic prostate cancer

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

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 has worsened, shown by rising PSA levels or changes in scans.

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My prostate cancer causes no or mild symptoms.

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I am a man aged 18 or older.

Select...

My PSA levels increased after stopping hormone therapy for prostate cancer.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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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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I am fully active or restricted in physically strenuous activity but can do light work.

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My testosterone levels are below 50 ng/dL due to treatment.

ERA 223 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of study treatment until 4 weeks after last study treatment, up to 65 months

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 2024 Phase 3 trial • 806 Patients • NCT02043678

39%

Back pain

26%

Fatigue

23%

Arthralgia

19%

Nausea

18%

Bone pain

18%

Constipation

18%

Diarrhoea

18%

Alanine aminotransferase increased

17%

Anaemia

17%

Decreased appetite

16%

Hypertension

16%

Aspartate aminotransferase increased

15%

Oedema peripheral

15%

Fall

13%

Pain in extremity

12%

Musculoskeletal pain

12%

Pathological fracture

11%

Traumatic fracture

11%

Hypokalaemia

11%

Dizziness

10%

Urinary tract infection

10%

Vomiting

Asthenia

Cough

Nasopharyngitis

Spinal pain

Headache

Insomnia

Haematuria

Upper respiratory tract infection

Contusion

Muscle spasms

Osteoporosis

Osteoporotic fracture

Pyrexia

Musculoskeletal chest pain

Influenza

Abdominal pain

Muscular weakness

Myalgia

Hot flush

Dyspepsia

Weight decreased

Dyspnoea

Neck pain

Pneumonia

Hyperglycaemia

Pelvic pain

General physical health deterioration

Influenza like illness

Squamous cell carcinoma of skin

Spinal cord compression

Pulmonary embolism

Thrombocytopenia

Neutropenic sepsis

Pulmonary sepsis

Dehydration

Osteonecrosis of jaw

Basal cell carcinoma

Colon cancer

Lung adenocarcinoma

Colorectal cancer

Syncope

Ischaemic stroke

Delirium

Urinary retention

Chronic obstructive pulmonary disease

Respiratory failure

Hypotension

Peripheral ischaemia

Acute myocardial infarction

Acute kidney injury

Sepsis

Non-cardiac chest pain

Sciatica

Transient ischaemic attack

Nephrolithiasis

Atrial fibrillation

Dysphagia

Febrile neutropenia

Neutropenia

Atrioventricular block complete

Myocardial infarction

Acute coronary syndrome

Multiple organ dysfunction syndrome

Lower respiratory tract infection

Cellulitis

Gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Abi/Pred

Radium-223 Dichloride + Abi/Pred

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

Prednisone/Prednisolone

2014

Completed Phase 3

~1410

Radium-223 dichloride (Xofigo, BAY88-8223)

2014

Completed Phase 3

~11100

Abiraterone

2012

Completed Phase 4

~2830

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,172 Total Patients Enrolled

39 Trials studying Prostate Cancer

25,919 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,383,502 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

The Lancet OncologyJournal

Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial

Smith, Matthew, Chris Parker, Fred Saad, Kurt Miller, Bertrand Tombal, Quan Sing Ng, Martin Boegemann, et al.. 2019. “Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30860-x.

Prostate Cancer and Prostatic DiseasesJournal

Concurrent or Layered Treatment with Radium-223 and Enzalutamide or Abiraterone/prednisone: Real-world Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer

Shore, Neal, Celestia S. Higano, Daniel J. George, Cora N. Sternberg, Fred Saad, Bertrand Tombal, Kurt Miller, et al.. 2020. “Concurrent or Layered Treatment with Radium-223 and Enzalutamide or Abiraterone/prednisone: Real-world Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer”. Prostate Cancer and Prostatic Diseases. Springer Science and Business Media LLC. doi:10.1038/s41391-020-0236-0.

International Journal of Clinical OncologyJournal

A Randomized, Double-blind, Comparison of Radium-223 and Placebo, in Combination with Abiraterone Acetate and Prednisolone, in Castration-resistant Metastatic Prostate Cancer: Subgroup Analysis of Japanese Patients in the ERA 223 Study

Matsubara, Nobuaki, Go Kimura, Hiroji Uemura, Hirotsugu Uemura, Motonobu Nakamura, Satoshi Nagamori, Atsushi Mizokami, et al.. 2019. “A Randomized, Double-blind, Comparison of Radium-223 and Placebo, in Combination with Abiraterone Acetate and Prednisolone, in Castration-resistant Metastatic Prostate Cancer: Subgroup Analysis of Japanese Patients in the ERA 223 Study”. International Journal of Clinical Oncology. Springer Science and Business Media LLC. doi:10.1007/s10147-019-01589-6.

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