Prostate Cancer Clinical Trial

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

Summary

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.

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Full 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). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received 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 SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data, or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in the extended safety follow-up study.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

806

Study ID:

NCT02043678

Recruitment Status:

Active, not recruiting

Sponsor:

Bayer

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There are 162 Locations for this study

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Anchorage Alaska, 99503, United States

Tucson Arizona, 85704, United States

Tucson Arizona, 85718, United States

Oceanside California, 92056, United States

Denver Colorado, 80211, United States

Washington District of Columbia, 20007, United States

Fort Myers Florida, 33901, United States

Atlanta Georgia, 30322, United States

Jeffersonville Indiana, 47130, United States

New Orleans Louisiana, 70112, United States

Baltimore Maryland, 21201, United States

Rockville Maryland, 20850, United States

Towson Maryland, 21204, United States

Boston Massachusetts, 02114, United States

Burlington Massachusetts, 01805, United States

Detroit Michigan, 48202, United States

Traverse City Michigan, 49684, United States

Saint Louis Missouri, 63110, United States

Omaha Nebraska, 68130, United States

Las Vegas Nevada, 89169, United States

Hackensack New Jersey, 07601, United States

Poughkeepsie New York, 12601, United States

Syracuse New York, 13210, United States

Bala-Cynwyd Pennsylvania, 19004, United States

Pittsburgh Pennsylvania, 15215, United States

Pittsburgh Pennsylvania, 15240, United States

Norfolk Virginia, 23502, United States

Seattle Washington, 98109, United States

Spokane Washington, 99208, United States

Wheeling West Virginia, 26003, United States

St Leonards New South Wales, 2065, Australia

Adelaide South Australia, 5000, Australia

East Bentleigh Victoria, 3165, Australia

Heidelberg Victoria, 3084, Australia

Melbourne Victoria, 3065, Australia

Darlinghurst , 2010, Australia

East Melbourne , 3002, Australia

Randwick , 2031, Australia

Anderlecht , 1070, Belgium

Bruxelles - Brussel , 1200, Belgium

Edegem , 2650, Belgium

Gent , 9000, Belgium

Belo Horizonte Minas Gerais, 30110, Brazil

Porto Alegre Rio Grande Do Sul, 90050, Brazil

Barretos Sao Paulo, 14784, Brazil

São Paulo Sao Paulo, 01246, Brazil

Sao Paulo , 01308, Brazil

Calgary Alberta, T2N 4, Canada

Vancouver British Columbia, V5Z 4, Canada

Winnipeg Manitoba, R3A 1, Canada

Hamilton Ontario, L8V 5, Canada

Ottawa Ontario, K1H 8, Canada

Toronto Ontario, M4N 3, Canada

Montreal Quebec, H2L 4, Canada

Quebec , G1R 2, Canada

Helsinki , 00290, Finland

Kuopio , 70210, Finland

Seinäjoki , 60220, Finland

Tampere , 33521, Finland

Besancon , 25030, France

Bordeaux Cedex , 33076, France

Paris , 75005, France

Paris , 75010, France

POITIERS cedex , 86021, France

Saint Herblain , 44805, France

Toulouse Cedex 9 , 31059, France

Ulm Baden-Württemberg, 89075, Germany

München Bayern, 81675, Germany

Marburg Hessen, 35043, Germany

Münster Nordrhein-Westfalen, 48149, Germany

Dresden Sachsen, 01307, Germany

Jena Thüringen, 07747, Germany

Berlin , 12203, Germany

Afula , 18341, Israel

Beer Sheva , 84101, Israel

Haifa , 31096, Israel

Jerusalem , 91120, Israel

Kfar Saba , 44281, Israel

Petach Tikva , 49414, Israel

Ramat Gan , 52620, Israel

Tel Aviv , 64239, Israel

Zrifin , 70300, Israel

Modena Emilia-Romagna, 41124, Italy

Roma Lazio, 00152, Italy

Roma Lazio, 00189, Italy

Genova Liguria, 16128, Italy

Milano Lombardia, 20133, Italy

Milano Lombardia, 20141, Italy

Cagliari Sardegna, 09125, Italy

Arezzo Toscana, 52100, Italy

Trento Trentino-Alto Adige, 38100, Italy

Nagoya Aichi, 466-8, Japan

Hirosaki Aomori, 036-8, Japan

Kashiwa Chiba, 277-8, Japan

Matsuyama Ehime, 791-0, Japan

Sapporo Hokkaido, 003-0, Japan

Kobe Hyogo, 650-0, Japan

Tsukuba Ibaraki, 305-8, Japan

Kanazawa Ishikawa, 920-8, Japan

Kita Kagawa, 761-0, Japan

Yokohama Kanagawa, 236-0, Japan

Yokohama Kanagawa, 241-8, Japan

Sendai Miyagi, 980-8, Japan

Matsumoto Nagano, 390-8, Japan

Kurashiki Okayama, 701-0, Japan

Osakasayama Osaka, 589-8, Japan

Hamamatsu Shizuoka, 431-3, Japan

Bunkyo-ku Tokyo, 113-8, Japan

Bunkyo-ku Tokyo, 113-8, Japan

Koto-ku Tokyo, 135-8, Japan

Shinjuku-ku Tokyo, 160-8, Japan

Ube Yamaguchi, 755-8, Japan

Chiba , 260-8, Japan

Chiba , 260-8, Japan

Fukuoka , 811-1, Japan

Fukuoka , 812-8, Japan

Kumamoto , 860-0, Japan

Miyazaki , 889-1, Japan

Nagasaki , 852-8, Japan

Okayama , 700-8, Japan

Amsterdam , 1105 , Netherlands

Nijmegen , 6525 , Netherlands

Zwolle , 8025 , Netherlands

Bodø , 8092, Norway

Lørenskog , 1478, Norway

Oslo , 0450, Norway

Gdansk , 80-95, Poland

Gdynia , 81-51, Poland

Gliwice , 44-10, Poland

Poznan , 61-48, Poland

Moscow , 11547, Russian Federation

Obninsk , 24903, Russian Federation

Singapore , 11907, Singapore

Singapore , 16961, Singapore

Singapore , 25849, Singapore

Oviedo Asturias, 33006, Spain

Badalona Barcelona, 08916, Spain

Hospitalet de Llobregat Barcelona, 08907, Spain

Barcelona , 08035, Spain

Barcelona , 08036, Spain

Madrid , 28007, Spain

Madrid , 28033, Spain

Madrid , 28034, Spain

Madrid , 28046, Spain

Madrid , 28050, Spain

Málaga , 29010, Spain

Pamplona , 31008, Spain

Sevilla , 41009, Spain

Linköping , 58185, Sweden

Stockholm , 171 7, Sweden

Sundsvall , 851 8, Sweden

Umeå , 901 8, Sweden

Växjö , 351 8, Sweden

Edinburgh Lothian, EH4 2, United Kingdom

Bebington Merseyside, CH63 , United Kingdom

Northwood Middlesex, HA6 2, United Kingdom

Guildford Surrey, GU2 7, United Kingdom

Sutton Surrey, SM2 5, United Kingdom

Newcastle Upon Tyne Tyne And Wear, NE4 6, United Kingdom

Coventry West Midlands, CV2 2, United Kingdom

Belfast , BT9 7, United Kingdom

Leeds , LS9 7, United Kingdom

London , NW3 2, United Kingdom

Romford , RM7 0, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

806

Study ID:

NCT02043678

Recruitment Status:

Active, not recruiting

Sponsor:


Bayer

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