Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 of 16 for:    alpharadin | Open Studies

Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms (ERA 223)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer Identifier:
First received: January 21, 2014
Last updated: October 30, 2014
Last verified: October 2014

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

Condition Intervention Phase
Prostatic Neoplasms
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Drug: Matching placebo (normal saline)
Drug: Abiraterone
Drug: Prednisone/Prednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Symptomatic skeletal event free survival (SSE-FS) [ Time Frame: At 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: At 3 years for interim and at 6 years for final ] [ Designated as safety issue: No ]
  • Time to opiate use for cancer pain [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Time to pain progression [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Time to cytotoxic chemotherapy [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Radiological progression free survival (rPFS) [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: March 2014
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radium-223 dichloride
Radium-223 dichloride +abiraterone+prednisone/prednisolone All study subjects will receive treatment with oral abiraterone acetate (1000 mg once daily), oral prednisone/prednisolone (5 mg twice daily), with best supportive care
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
50 kBq/kg body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles
Drug: Abiraterone
All study subjects will receive treatment with oral abiraterone acetate (1000 mg once daily),with best supportive care
Drug: Prednisone/Prednisolone
All study subjects will receive treatment with oral prednisone/prednisolone (5 mg twice daily), with best supportive care
Placebo Comparator: Placebo
Placebo+abiraterone+prednisone/prednisolone All study subjects will receive treatment with oral abiraterone acetate (1000 mg once daily), oral prednisone/prednisolone (5 mg twice daily), with best supportive care
Drug: Matching placebo (normal saline)
Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles
Drug: Abiraterone
All study subjects will receive treatment with oral abiraterone acetate (1000 mg once daily),with best supportive care
Drug: Prednisone/Prednisolone
All study subjects will receive treatment with oral prednisone/prednisolone (5 mg twice daily), with best supportive care

Detailed Description:

This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone).The study period will consist of screening/randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and long-term follow-up phases. In this study, subjects will receive study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone/prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone/prednisolone thereafter) until an on-study symptomatic skeletal event (SSE) occurs (or other withdrawal criteria are met). Follow-up will continue for up to 7 years or until the subject dies, is lost to followup, or withdraws informed consent and actively objects to collection of further data.This study will be conducted at approximately 150 investigative study centers and approximately 800 subjects will be enrolled.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Male subjects of age ≥ 18 years
  • Prostate cancer progression documented by prostate specific antigen 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.
  • Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis.
  • Asymptomatic or mildly symptomatic prostate cancer.
  • Subjects who received combined androgen blockade with an anti-androgen must have shown PSA(prostate specific antigen) progression after discontinuing the anti-androgen prior to enrollment.
  • Medical or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
  • Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
  • Pathological finding consistent with small cell carcinoma of the prostate
  • History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
  • History of or known brain metastasis.
  • Malignant lymphadenopathy exceeding 3 cm in short-axis diameter.
  • Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02043678

Contact: Bayer Clinical Trials Contact
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 158 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT02043678     History of Changes
Other Study ID Numbers: 15396, 2013-003438-33
Study First Received: January 21, 2014
Last Updated: October 30, 2014
Health Authority: Australia: Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Sanitary Vigilance Agency (ANVISA)
Canada: Health Canada
Finland: Finnish Medicines Agency
France: National Agency for the Safety of Medicine and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Israel: State of Israel Ministry of Health
Italy: Italian Medicines Agency
Japan: Japanese Pharmaceuticals and Medical Devices Agency
Netherlands: Medicines Evaluation Board
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of Russian Federation
Spain: Spanish Agency for Medicines and Health Products
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Phase III
Radium-223 dichloride
Abiraterone acetate
Combination therapy
Bone metastasis
Castration-resistant prostate cancer (CRPC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Neuroprotective Agents processed this record on November 20, 2014