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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
Must not have
History of or known brain metastasis
Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
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

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.

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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had brain metastasis.
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I have received chemotherapy for prostate cancer.
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I take more than 5 mg of prednisone or similar medication twice daily for a chronic condition.
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My prostate cancer is of the small cell type.
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My cancer has spread to my internal organs.
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My cancer has spread to lymph nodes larger than 3 cm.
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I have used opiate painkillers for cancer pain in the last 4 weeks.

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 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
9%
Asthenia
9%
Cough
8%
Nasopharyngitis
8%
Spinal pain
8%
Headache
8%
Insomnia
8%
Haematuria
7%
Upper respiratory tract infection
7%
Contusion
7%
Muscle spasms
7%
Osteoporosis
7%
Osteoporotic fracture
7%
Pyrexia
7%
Musculoskeletal chest pain
6%
Influenza
6%
Abdominal pain
6%
Muscular weakness
6%
Myalgia
6%
Hot flush
5%
Dyspepsia
5%
Weight decreased
5%
Dyspnoea
4%
Neck pain
3%
Pneumonia
3%
Hyperglycaemia
3%
Pelvic pain
3%
General physical health deterioration
3%
Influenza like illness
2%
Squamous cell carcinoma of skin
2%
Spinal cord compression
2%
Pulmonary embolism
1%
Thrombocytopenia
1%
Neutropenic sepsis
1%
Pulmonary sepsis
1%
Dehydration
1%
Osteonecrosis of jaw
1%
Basal cell carcinoma
1%
Colon cancer
1%
Lung adenocarcinoma
1%
Colorectal cancer
1%
Syncope
1%
Ischaemic stroke
1%
Delirium
1%
Urinary retention
1%
Chronic obstructive pulmonary disease
1%
Respiratory failure
1%
Hypotension
1%
Peripheral ischaemia
1%
Acute myocardial infarction
1%
Acute kidney injury
1%
Sepsis
1%
Non-cardiac chest pain
1%
Sciatica
1%
Transient ischaemic attack
1%
Nephrolithiasis
1%
Atrial fibrillation
1%
Dysphagia
1%
Febrile neutropenia
1%
Neutropenia
1%
Atrioventricular block complete
1%
Myocardial infarction
1%
Acute coronary syndrome
1%
Multiple organ dysfunction syndrome
1%
Lower respiratory tract infection
1%
Cellulitis
1%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Abi/Pred
Radium-223 Dichloride + Abi/Pred

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
2017
Completed Phase 3
~2510
Radium-223 dichloride (Xofigo, BAY88-8223)
2014
Completed Phase 3
~11100
Abiraterone
2012
Completed Phase 4
~3580

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,251 Previous Clinical Trials
25,336,110 Total Patients Enrolled
42 Trials studying Prostate Cancer
26,124 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLCIndustry Sponsor
980 Previous Clinical Trials
6,383,487 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,073 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
~72 spots leftby Jul 2025
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