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.
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 this study or in the extended safety follow-up study.
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.
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There are 162 Locations for this study
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
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, 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, 90020, Brazil
Barretos/SP 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
Québec 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 , 44800, 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 , 80-21, 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 , 16858, Singapore
Singapore , 25849, Singapore
Oviedo Asturias, 33006, Spain
Badalona Barcelona, 08916, Spain
Hospitalet de Llobregat Barcelona, 08907, Spain
Malaga Málaga, 29010, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Madrid , 28050, 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
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