Trial Condition(s):

Prostatic Neoplasms

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)

Bayer Identifier:

15396

ClinicalTrials.gov Identifier:

NCT02043678

EudraCT Number:

2013-003438-33

Recruitment Complete

Trial Purpose

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.

Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate
 - Male subjects of age ≥ 18 years
 - 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
 - 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 progression after discontinuing the anti-androgen prior to enrollment
 - Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)
 - Eastern Cooperative Oncology Group performance status (ECOG PS) score 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 twice daily
 - 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.

Trial Summary

Enrollment Goal
806
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kfar Saba, Israel, 4428164

Status
Active, not recruiting
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Petach Tikva, Israel, 4941492

Status
Active, not recruiting
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Kuopio, Finland, 70210

Status
Completed
 
Locations

Investigative Site

Seinäjoki, Finland, 60220

Status
Active, not recruiting
 
Locations

Investigative Site

Helsinki, Finland, 00290

Status
Completed
 
Locations

Investigative Site

Tampere, Finland, 33521

Status
Active, not recruiting
 
Locations

Investigative Site

Berlin, Germany, 12203

Status
Completed
 
Locations

Investigative Site

Sutton, United Kingdom, SM2 5PT

Status
Active, not recruiting
 
Locations

Investigative Site

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Investigative Site

GENT, Belgium, 9000

Status
Completed
 
Locations

Investigative Site

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Investigative Site

Romford, United Kingdom, RM7 0AG

Status
Completed
 
Locations

Investigative Site

Bebington, United Kingdom, CH63 4JY

Status
Completed
 
Locations

Investigative Site

Northwood, United Kingdom, HA6 2VR

Status
Completed
 
Locations

Investigative Site

Coventry, United Kingdom, CV2 2DX

Status
Active, not recruiting
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08035

Status
Completed
 
Locations

Investigative Site

Oviedo, Spain, 33006

Status
Completed
 
Locations

Investigative Site

Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28046

Status
Completed
 
Locations

Investigative Site

Pamplona, Spain, 31008

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28034

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28033

Status
Completed
 
Locations

Investigative Site

Pamplona, Spain, 31008

Status
Active, not recruiting
 
Locations

Investigative Site

Badalona, Spain, 08916

Status
Completed
 
Locations

Investigative Site

Umeå, Sweden, 901 85

Status
Completed
 
Locations

Investigative Site

New Orleans, United States, 70112

Status
Completed
 
Locations

Investigative Site

Bodø, Norway, 8092

Status
Completed
 
Locations

Investigative Site

Lørenskog, Norway, 1478

Status
Completed
 
Locations

Investigative Site

Oslo, Norway, 0450

Status
Completed
 
Locations

Investigative Site

Baltimore, United States, 21201

Status
Active, not recruiting
 
Locations

Investigative Site

Detroit, United States, 48202

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98109-1023

Status
Completed
 
Locations

Investigative Site

Rockville, United States, 20850

Status
Completed
 
Locations

Investigative Site

PARIS, France, 75010

Status
Active, not recruiting
 
Locations

Investigative Site

PARIS, France, 75005

Status
Completed
 
Locations

Investigative Site

BESANCON, France, 25030

Status
Completed
 
Locations

Investigative Site

Bordeaux Cedex, France, 33076

Status
Completed
 
Locations

Investigative Site

TOULOUSE CEDEX 9, France, 31059

Status
Completed
 
Locations

Investigative Site

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Investigative Site

Ulm, Germany, 89075

Status
Terminated
 
Locations

Investigative Site

München, Germany, 81675

Status
Active, not recruiting
 
Locations

Investigative Site

Dresden, Germany, 01307

Status
Completed
 
Locations

Investigative Site

Marburg, Germany, 35043

Status
Completed
 
Locations

Investigative Site

Pittsburgh, United States, 15215

Status
Completed
 
Locations

Investigative Site

Gdansk, Poland, 80-214

Status
Completed
 
Locations

Investigative Site

Gdynia, Poland, 81-519

Status
Completed
 
Locations

Investigative Site

Gliwice, Poland, 44-101

Status
Completed
 
Locations

Investigative Site

Arezzo, Italy, 52100

Status
Completed
 
Locations

Investigative Site

Genova, Italy, 16128

Status
Completed
 
Locations

Investigative Site

Växjö, Sweden, 351 85

Status
Completed
 
Locations

Investigative Site

Atlanta, United States, 30322

Status
Completed
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1105 AZ

Status
Active, not recruiting
 
Locations

Investigative Site

Melbourne, Australia, 3065

Status
Completed
 
Locations

Investigative Site

Darlinghurst, Australia, 2010

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5000

Status
Completed
 
Locations

Investigative Site

Ottawa, Canada, K1H 8L6

Status
Active, not recruiting
 
Locations

Investigative Site

Belo Horizonte, Brazil, 30110-090

Status
Completed
 
Locations

Investigative Site

Boston, United States, 02114-2696

Status
Active, not recruiting
 
Locations

Investigative Site

São Paulo, Brazil, 01246-000

Status
Active, not recruiting
 
Locations

Investigative Site

Zrifin, Israel, 7030000

Status
Active, not recruiting
 
Locations

Investigative Site

East Melbourne, Australia, 3002

Status
Completed
 
Locations

Investigative Site

Leeds, United Kingdom, LS9 7TF

Status
Active, not recruiting
 
Locations

Investigative Site

Belfast, United Kingdom, BT9 7AB

Status
Active, not recruiting
 
Locations

Investigative Site

Guildford, United Kingdom, GU2 7XX

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20133

Status
Completed
 
Locations

Investigative Site

Trento, Italy, 38100

Status
Completed
 
Locations

Investigative Site

Vancouver, Canada, V5Z 4E6

Status
Completed
 
Locations

Investigative Site

Québec, Canada, G1R 2J6

Status
Completed
 
Locations

Investigative Site

Fort Myers, United States, 33901

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00152

Status
Active, not recruiting
 
Locations

Investigative Site

Cagliari, Italy, 09125

Status
Active, not recruiting
 
Locations

Investigative Site

NIJMEGEN, Netherlands, 6525 GA

Status
Active, not recruiting
 
Locations

Investigative Site

Obninsk, Russia, 249036

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20007-2113

Status
Active, not recruiting
 
Locations

Investigative Site

Barretos, Brazil, 14784-400

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Active, not recruiting
 
Locations

Investigative Site

Singapore, Singapore, 258499

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119074

Status
Active, not recruiting
 
Locations

Investigative Site

Jena, Germany, 07747

Status
Completed
 
Locations

Investigative Site

Porto Alegre, Brazil, 90050-170

Status
Completed
 
Locations

Investigative Site

Wheeling, United States, 26003

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99208-1129

Status
Completed
 
Locations

Investigative Site

Burlington, United States, 01805

Status
Completed
 
Locations

Investigative Site

Hackensack, United States, 07601

Status
Completed
 
Locations

Investigative Site

Traverse City, United States, 49684

Status
Completed
 
Locations

Investigative Site

Modena, Italy, 41124

Status
Active, not recruiting
 
Locations

Investigative Site

Roma, Italy, 00189

Status
Completed
 
Locations

Investigative Site

Linköping, Sweden, 58185

Status
Completed
 
Locations

Investigative Site

Tucson, United States, 85718

Status
Completed
 
Locations

Investigative Site

Winnipeg, Canada, R3A 1R9

Status
Active, not recruiting
 
Locations

Investigative Site

Omaha, United States, 68130

Status
Completed
 
Locations

Investigative Site

Oceanside, United States, 92056

Status
Completed
 
Locations

Investigative Site

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Investigative Site

Montreal, Canada, H2L 4M1

Status
Active, not recruiting
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Active, not recruiting
 
Locations

Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8603

Status
Active, not recruiting
 
Locations

Investigative Site

Sapporo, Japan, 003-0804

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8717

Status
Active, not recruiting
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Active, not recruiting
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Active, not recruiting
 
Locations

Investigative Site

Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8431

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 431-3192

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 236-0004

Status
Active, not recruiting
 
Locations

Investigative Site

Edinburgh, United Kingdom, EH4 2XU

Status
Completed
 
Locations

Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 01308-050

Status
Active, not recruiting
 
Locations

Investigative Site

Pittsburgh, United States, 15240

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89169

Status
Completed
 
Locations

Investigative Site

Norfolk, United States, 23502

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20141

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-0008

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Investigative Site

Newcastle Upon Tyne, United Kingdom, NE4 6BE

Status
Completed
 
Locations

Investigative Site

Münster, Germany, 48149

Status
Completed
 
Locations

Investigative Site

Moscow, Russia, 115478

Status
Completed
 
Locations

Investigative Site

Calgary, Canada, T2N 4N2

Status
Completed
 
Locations

Investigative Site

Kita, Japan, 761-0793

Status
Completed
 
Locations

Investigative Site

Randwick, Australia, 2031

Status
Active, not recruiting
 
Locations

Investigative Site

Anderlecht, Belgium, 1070

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 241-8515

Status
Completed
 
Locations

Investigative Site

Miyazaki, Japan, 889-1692

Status
Completed
 
Locations

Investigative Site

Hirosaki, Japan, 036-8563

Status
Completed
 
Locations

Investigative Site

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Investigative Site

St Leonards, Australia, 2065

Status
Completed
 
Locations

Investigative Site

Matsumoto, Japan, 390-8621

Status
Completed
 
Locations

Investigative Site

Ube, Japan, 755-8505

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 852-8501

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 811-1395

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 61-485

Status
Completed
 
Locations

Investigative Site

Kurashiki, Japan, 701-0192

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0047

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Investigative Site

Bala Cynwyd, United States, 19004

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63110

Status
Completed
 
Locations

Investigative Site

Tsukuba, Japan, 305-8576

Status
Completed
 
Locations

Investigative Site

East Bentleigh, Australia, 3165

Status
Active, not recruiting
 
Locations

Investigative Site

Towson, United States, 21204

Status
Completed
 
Locations

Investigative Site

Poughkeepsie, United States, 12601

Status
Completed
 
Locations

Investigative Site

Jeffersonville, United States, 47130

Status
Completed
 
Locations

Investigative Site

Denver, United States, 80211

Status
Completed
 
Locations

Investigative Site

POITIERS cedex, France, 86021

Status
Completed
 
Locations

Investigative Site

Anchorage, United States, 99503

Status
Completed
 
Locations

Investigative Site

Syracuse, United States, 13210

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41009

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28050

Status
Completed
 
Locations

Investigative Site

Málaga, Spain, 29010

Status
Completed
 
Locations

Investigative Site

Saint-Herblain, France, 44800

Status
Active, not recruiting
 
Locations

Investigative Site

Tucson, United States, 85704

Status
Completed
 
Locations

Investigative Site

Afula, Israel, 1834111

Status
Completed
 

Trial Design