登记号
CTR20130169
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
转移性，去势难治性前列腺癌
试验通俗题目
他奎莫德治疗转移性，去势难治性前列腺癌的研究
试验专业题目
在转移性，去势难治性前列腺癌患者中进行的一项3期，随机化，双盲，安慰剂对照的他奎莫德研究
试验方案编号
10TASQ10
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
刘颖
联系人座机
+8610 5630 7598
联系人手机号
联系人Email
Yingg.liu@ipsen.com
联系人邮政地址
博福-益普生(天津)制药有限公司，北京市朝阳区曙光西里5号凤凰置地广场H座12层1206
联系人邮编
100028
临床试验信息
试验分类
有效性
试验分期
III期
试验目的
此研究的主要目的，是确证他奎莫德与安慰剂比较，在延迟疾病进展或死亡方面的效果。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
18（台湾20）岁(最小年龄)至
无岁(最大年龄)
性别
男
健康受试者
无
入选标准
- 在签署ICF时年龄至少18岁。台湾患者的最低年龄为20岁。
- 经组织学证实的前列腺腺癌诊断。
- 无论是骨骼扫描还是其它成像手段，放射学检查具有骨骼转移性疾病的证据。
- 去势水平的血清睾丸酮(小于等于50 ng/dL或1.7 nmol/L)。
- 具有进展性疾病的证据，并且不符合下述四项标准中的两项以上：前列腺特异性抗原(PSA)>100，Gleason评分≥8，有内脏转移（除淋巴结和局部复发外的所有软组织转移），和骨显像提示超过中轴骨以外的骨骼病变。
- Karnofsky分数大于等于70%。
- 实验室数值如下：血红蛋白大于或等于100克/升（大于10克/分升）；中性粒细胞绝对数大于或等于1500/微升；血小板大于或等于100 000/微升；血清肌酐小于或等于1.5倍正常上限（ULN）；总胆红素小于或等于1.5倍ULN；天门冬氨酸氨基转移酶和丙氨酸氨基转移酶小于或等于3倍ULN
- 在研究药物治疗期间如果与生育潜能伴侣存在性生活，患者将同意采取适宜的避孕方法（具有杀精子剂的屏障避孕品或输精管切除术）。在患者停止接受研究药物治疗后，适宜的避孕方法应继续保持14天。
- 没有既往（5年内）恶性肿瘤的证据（成功治疗的皮肤基底细胞或鳞状细胞癌除外）。
- 能够吞咽和保持口服药物治疗。
- 能够遵守研究访视计划和其它方案要求。
- 能够理解研究的全部性质和目的，包括可能的风险和副作用；能够与研究者合作，并遵守整个研究的要求。
- 在被告知了研究的全部性质和目的，包括可能的风险和副作用，并被提供了充足的时间和机会阅读和理解此信息后，能够（或患者的法定监护人，如果适用）签署书面知情同意并注明日期。
排除标准
- 研究治疗前2年内曾因前列腺癌接受过细胞毒素化疗或4周内曾使用过艾去适（雌氮芥）。
- 研究治疗开始前四周内曾因抗癌接受过放疗、生物药物或疫苗治疗，包括阿比特龙，TAK-700（Orteronel）或MDV3100，或在两周内曾接受过sipuleucel-T (Provenge) 。如果在基线扫描之后进行了放射治疗，需要在放射治疗后至少4周进行一次新的基线扫描。
- 在治疗前的过去4周内接受过抗雄激素治疗（比卡鲁胺如康士得为6周内）。
- 其它抗癌药物或治疗的伴随使用，下列情况除外： 正在进行的黄体生成素释放激素（LHRH）激动剂或拮抗剂，狄诺塞麦（Prolia），或二磷酸盐（如唑来膦酸）治疗是允许的。正在进行的治疗应维持在一个稳定的计划；但如果医学上需要，剂量改变，化合物改变，或二者均改变是允许的。
- 在开始研究治疗前4周内涉及大手术的任何治疗方案。
- 需要正在进行的麻醉性镇痛药治疗，或需要启动放疗或化疗的前列腺癌疼痛。
- 正在接受华法林治疗，除非国际标准化比率（INR）控制良好且低于4
- 相当于强的松龙或强的松剂量10mg/day以上的皮质类固醇维持治疗。剂量必须已经稳定至少5天。
- 在开始研究治疗前14天内酮康唑或其它强效细胞色素P450（CYP）3A4同工酶抑制剂或诱导剂的全身暴露。在开始研究治疗前1年内乙胺碘呋酮的全身暴露是不允许的。
- 在开始研究治疗时正在进行的敏感性CYP1A2底物或治疗范围较窄的CYP1A2底物治疗。
- 在开始研究治疗时正在进行的治疗范围较窄的CYP3A4底物治疗。
- 同时参加涉及研究药物治疗的其它研究，或在开始研究治疗前4周内接受过研究药物治疗。
- 在开始研究治疗前6个月内患有心肌梗塞，经皮冠状动脉插管，急性冠状动脉综合征，冠状动脉旁路移植，III/IV级充血性心力衰竭，脑血管意外，短暂性缺血发作，或静息时肢体跛行，和正在发作的症状性心律失常，不稳定心绞痛，未控制的高血压，和未控制的房性或室性心律失常。
- 胰腺炎病史。
- 已知的脑或硬膜外转移。
- 已知的HIV阳性血清学（由于免疫缺陷宿主不可预期的毒性和病态潜能，具有已知HIV病史的患者将被排除）。
- 具有晚期代偿失调性肝脏疾病，或肝硬化，或慢性病毒性肝炎病史，或已知为病毒性肝炎携带者的慢性肝炎（已经治愈的肝炎患者将被允许入组研究）。
- 患有活动性结核病（TB），或患有已知未治疗的潜伏性TB的患者。（国家特异性TB治疗应在开始研究治疗前至少30天已经实施，且患者应计划完成整个疗程。）
- 如果患者参加研究，可混淆研究数据的解释能力，或使患者处于不能接受的风险的任何情况，包括其它活动性或潜伏性感染，医学或精神疾病，或实验室异常的存在。
- 根据研究者意见不应参加研究的任何患者。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:他奎莫德胶囊
|
用法用量:胶囊；规格0.25，0.5，1mg；口服，每天一次以个体可耐受剂量0.25、0.5或1mg/天治疗，直至退出治疗标准，包括疾病进展而需要备选抗肿瘤治疗；反复支持性药物治疗和减量或停药后耐受性仍很差；对方案有重大不依从；需使用方案禁用的伴随药物，除非经允许；收回进一步治疗的同意；研究者或申办方的要求
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
用法用量:胶囊；规格 匹配0.25，0.5，1mg;口服，每天一次以个体可耐受剂量0.25、0.5或1mg/天治疗，直至退出治疗标准，包括疾病进展而需要备选抗肿瘤治疗；反复支持性药物治疗和减量或停药后耐受性仍很差；对方案有重大不依从；需使用方案禁用的伴随药物，除非经允许；收回进一步治疗的同意；研究者或申办方的要求
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 无疾病进展生存期 | 规定为随机化分组日期至放射学进展或死亡日期的时间 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| Micheal Carducci, M.D. | 美国内科医师协会会员 | +1 41-614 3977 | Carducci@jhmi.edu | 1M59 CRB1 Baltimore, MD 21231 USA | 1650 | John Hopkins Kimmel Cancer Center | |
| 叶定伟，医学博士 | 科室主任 | +86 10 13701663571 | dwyeli@yahoo.com.cn | 上海市东安路270号 | 200030 | 复旦大学附属肿瘤医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| John Hopkins Kimmel Cancer Center | Michael Carducci | UNITED STATES | NA | Baltimore |
| 复旦大学附属肿瘤医院 | 叶定伟 | 中国 | 上海 | 上海 |
| 复旦大学附属华山医院 | 丁强 | 中国 | 上海 | 上海 |
| 成都军区总医院 | 王亮 | 中国 | 四川 | 成都 |
| 汕头大学医学院第二附属医院 | 郑俊鸿 | 中国 | 广东 | 汕头 |
| 武汉大学中南医院国家药物临床试验机构 | 周福祥 | 中国 | 湖北 | 武汉 |
| 南昌大学附属第一医院 | 王共先 | 中国 | 江西省 | 南昌 |
| 中国人民解放军第三〇七医院 | 陈立军 | 中国 | 北京 | 北京 |
| Coffs Harbour Health | Karen Briscoe | AUSTRALIA | NA | Coffs Harbour |
| Australian Prostate Cancer Research Centre@ Epworth | Anthony Costello | AUSTRALIA | NA | Richmond, VIC |
| St John of God Hospital | siobhan Ng | AUSTRALIA | NA | Subiaco |
| St Vincent's Hospital | Richard Epstein | AUSTRALIA | NA | Darlinghurst |
| Royal Prince Alfred | Lisa Horvath | AUSTRALIA | NA | Camperdown |
| Cairns Base Hospital | Muhammad Islam | AUSTRALIA | NA | Cairns |
| Orchid Nursing Home | Gouri Shankar. Bhattacharyya | INDIA | NA | Kolkata |
| Jehangir Clinical Development Centre | B.D Kashyapi | INDIA | NA | Pune |
| Monilek Hospital& Research Centre | sunder lal .Tolani | INDIA | NA | Jaipur |
| Amrita Institute of Medical Sciences | Ginil Kumar | INDIA | NA | Elamakkara |
| Christian Medical College Hospital | Kim Mammen | INDIA | NA | Ludhiana |
| Tata Memorial Hospital | Vanita Noronha | INDIA | NA | Maharashtra |
| Shatabdi Superspeciality Hospital | Shailesh Bondarde | INDIA | NA | Mumbai Naka |
| Tauranga Urology Research Ltd | Peter Gilling | NEW ZEALAND | NA | Tauranga |
| Cardinal Points Specialist Centre | Anthony Nixon | NEW ZEALAND | NA | Whangarei |
| CURT Medical Trials Trust Board Inc. | Frank Kueppers | NEW ZEALAND | NA | Christchurch |
| Roundhay Medical Centre | Patrick Meffan | NEW ZEALAND | NA | Nelson |
| Palmerston North Hospital | Quinten King | NEW ZEALAND | NA | Palmerston North |
| Gangnam Severance Hospital | Byung Ha Chung | SOUTH KOREA | NA | Seoul |
| CHONNAM NATIONAL UNIVERSITY HOSPITAL | TAKE WON KANG | SOUTH KOREA | NA | Gwangju |
| Seoul St. Mary's Hospital | Sae Woong Kim | SOUTH KOREA | NA | Seoul |
| Samsung Medical Center | HYUN MOO. LEE | SOUTH KOREA | NA | Seoul |
| ASAN Medical Centre | Choung-Soo Kim | SOUTH KOREA | NA | Seoul |
| Severance Hospital, Yonsei University Healthcare system | Hong Sung .Joon | SOUTH KOREA | NA | Seoul |
| Seoul National University Hospital | Cheol Kwak | SOUTH KOREA | NA | Seoul |
| Chang Gung Mecical Foundation-Linkou Branch | Cheng-Keng Chuang | 中国 | NA | Taoyuan |
| Taichung Veterans General Hospital | Yen-Chuan Ou | 中国 | NA | Taichung |
| National Taiwan University Hospital | Yu-chieh Tsai | 中国 | NA | Taipei |
| Kaohsiung Veterans General Hospital | Tony Wu | 中国 | NA | Kaohsiung |
| Centro Oncologico Agave | Natalia Broglia | ARGENTINA | NA | Venado Tuerto (Sta Fe). |
| IMAI Research | Silvia Carraro | ARGENTINA | NA | C.A.B.A |
| CDU | Luis. Montes de Oca | ARGENTINA | NA | C.A.B.A |
| Fundacion Koriza | Pablo Picon | ARGENTINA | NA | Santa Rosa- La Pampa |
| Hospital Italiano de Buenos Aires | Maria Pallota | ARGENTINA | NA | C.A.B.A |
| Centro de Pesquisas Clinicas em Oncologia | Sabina Aleixo | BRAZIL | NA | Cachoeiro de Itapemirim |
| CMIP-CENTRO MINEIRO DE PESQUISA | CHRISTIANE ALVES | BRAZIL | NA | JUIZ DE FORA-MG |
| Oncotrat Oncologia Medica Ltda | Iane Cardoso | BRAZIL | NA | Rio de Janeiro |
| LIGA NORTE RIOGRANDENSE CONTRA O CANCER | DANIELLI MATIAS | BRAZIL | NA | NATAL/RN |
| CEPON | Yeni Veronica. Neron do Nascimento | BRAZIL | NA | Florianopolis |
| ONCOVIDA | ALBERTO NOGUEIRA | BRAZIL | NA | SALVADOR |
| Premier Residence Hospital | Roberto. Odebrecht Rocha | BRAZIL | NA | sao paulo |
| Centro Oncologico de Mogi das Cruzes | Daniel .Grabarz (Dr Rodriguez, Flavio) | BRAZIL | NA | Mogi das Cruzes |
| Hospital da Cidade de Passo Fundo | Luis Alberto. Schlittler | BRAZIL | NA | Passo Fundo |
| HCPA | Gilberto Schwartsmann | BRAZIL | NA | Porto Alegre |
| Rio Sul Centro Pesquisa Clinica | Leonardo Osorio | BRAZIL | NA | Rio de Janeiro |
| Universidade Estadual Paulista Julio de Mesquita Filho | Guareide Carelli | BRAZIL | NA | Botucatu |
| Hospital Erasto Gaertner | FLAVIO. SAAVEDRA TOMASICH | BRAZIL | NA | Curitiba |
| Fundacao Pio XII - Hospital de Cancer de Barretos | Flavio. Mavignier Carcano | BRAZIL | NA | Barretos |
| ONCOVIDA | Alejandro. Acevedo Gaete | CHILE | NA | VINA DEL MAR |
| Centro de especialidades medicas | Mario GORENA | CHILE | NA | TEMUCO |
| UROMED CLINIC | Anibal. Salazar Huerta | CHILE | NA | SANTIAGO |
| HOSPITAL DIPRECA | Luis .SOTO DIAZ | CHILE | NA | SANTIAGO |
| HOSCAR | Nelson .Orellana Salinas | CHILE | NA | SANTIAGO |
| FUNDACION VALLE DEL LILI | Manuel .Duque Galan | COLOMBIA | NA | CALI |
| FUNDACION SANTA FE | CARLOS VARGAS | COLOMBIA | NA | BOGOTA |
| CAFAM | LUIS AMADOR | COLOMBIA | NA | BOGOTA |
| Hospital Angeles Puebla | JOSE. ARROYO KURIBRENA | MEXICO | NA | PUEBLA |
| HRDEB | Marco. Badillo Santoyo | MEXICO | NA | LEON |
| CHRISTUS MUGUERZA DEL PARQUE | ROBERTO .HIDALGO-SILVA | MEXICO | NA | CHIHUAHUA CHIHUAHUA |
| HOSPITAL ANGELES CULIACAN | GUSTAVO GAXIOLA-MEZA | MEXICO | NA | CULIACAN, SINALOA |
| Hospital Universitario Dr. José Eleuterio Gonzalez Universidad Autonoma de Nuevo Leon | LAURO .GOMEZ GUERRA | MEXICO | NA | Monterrey |
| PRIVATE OFFICE | JOSE ARTURO .RODRIGUEZ RIVERA | MEXICO | NA | ZAPOPAN |
| Centro Hemato Oncologico | Juan Pablo .Bares Weeden | PANAMA | NA | Panama |
| Clinica San Fernando | Javier. Del Rosario Gibbs | PANAMA | NA | Panama |
| Medical Reaserch Center | Roberto LOPEZ | PANAMA | NA | Panama |
| Caja de Seguro Social Hospital metropolitano | Alejandro Manduley | PANAMA | NA | Panama |
| Servicio de Medicina Oncologica - Hospital Goyeneche | Ernesto. Andres Vargas Quesada | PERU | NA | Arequipa - PERU |
| HOSPITAL CASE AREQUIPA | David .Moron Escobar | PERU | NA | Arequipa |
| CHU Liege | Brieuc Sautois | BELGIUM | NA | LIEGE |
| AZ Groeninge Kortrijk | Patrick Werbrouck | BELGIUM | NA | Kortrijk |
| ULB Erasme Hospital | Th. Roumeguere | BELGIUM | NA | Brussels |
| AZ Maria Middelares | Filip Ameye | BELGIUM | NA | Gent |
| District dispensary for oncolog. diseases with inpatient unit-sofia sity | Borislav Dimitrov | BULGARIA | NA | sofia |
| Interdistrict Dispensary for Oncology Diseases with Inpatient Sector – Ruse Chemotherapy Department | Katerina Guenova | BULGARIA | NA | Rousse |
| MHAT Sveta Marina – Varna | Dimitar Kalev | BULGARIA | NA | Varna |
| District Dispensary for Oncology Diseases with Inpatient Unit-Plovdiv, Second Internal Department | Petar Petrov | BULGARIA | NA | Plovdiv |
| Interdistrict Dispensary for Oncology Diseases with Inpatient Unit “Dr. Marko Antonov Markov” - Varna Department of Medical Oncotherapy and Palliative Care | Violina Taskova | BULGARIA | NA | Varna |
| University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL Clinic of Oncotherapy | Assen Dudov | BULGARIA | NA | Sofia |
| UMHAT D-r Georgi Stranski | Rumyana Micheva | BULGARIA | NA | Pleven |
| Kromerizska nemocnice a.s. | Lumir Domes | CZECH REPUBLIC | NA | Kromeriz |
| Department of Urology, Hospital Motol | Josef Stolz | CZECH REPUBLIC | NA | Praha 5 |
| Urocentrum Praha | Michaela Matouskova | CZECH REPUBLIC | NA | Praha 2 |
| Department of Urology, Masaryk hospital Usti nad Labem | Jan Schram | CZECH REPUBLIC | NA | Usti nad Labem |
| Department of Urology, Hospital Novy Jicin | Miroslav Stursa | CZECH REPUBLIC | NA | Novy Jicin |
| Urology Clinics of the Faculty Hospital Olomouc | Vladimir STUDENT | Czech Republic | NA | Olomouc |
| Tartu University Hospital, Surgery Clinic, Dep. of urology and renal transplantation | Kahu Jaanus | ESTONIA | NA | Tartu |
| East Tallinn Central Hospital, Surgery Clinic, Department of Urology | Tamm Toomas | ESTONIA | NA | Tallinn |
| Cannes hospital | Regis Kaphan | FRANCE | NA | Cannes |
| CHU Lapeyronie | Xavier Rebillard | France | NA | Montpellier |
| Hopital Foch | Christine Theodore | France | NA | Suresnes |
| Centre Regional de lutte contre le cancer Paul Papin | Remy Delva | France | NA | Angers |
| Centre hospitalier Lyon Sud | Alain RUFFION | France | NA | PIERRE-BENITE |
| CRLC Val d'Aurelle | David Azria | France | NA | Montpellier |
| N.H.C. H.U.S. | Didier Jacqmin | France | NA | Strasbourg |
| Centre Eugene Marquis | Vincent VINCENDEAU-RECOQUILLON | France | NA | RENNES |
| Institut Curie | Philippe Beuzeboc | France | NA | Paris |
| Paris at Saint-Louis Hospital | Stephane Culine | France | NA | Creteil |
| Hopsital Nord | Marjorie BACIUCHKA-PALMARO | France | NA | Marseille |
| CHU de la Timone | Jean Laurent. DEVILLE | France | NA | Marseille |
| Universitatsklinik fur Urologie | Arnulf Stenzl | GERMANY | NA | Tubingen |
| Urologische Studienpraxis | Susan Feyerabend | GERMANY | NA | Nurtingen |
| Universitatsklinikum Munster. Klinik und Polikklinik fur Urologie | Martin Bogemann | GERMANY | NA | Munster |
| Kliniken Nordoberpfalz AG, Klinikum Weiden | Theodor klotz | GERMANY | NA | Weiden |
| Klinik fur Urologie und Kinderurologie, Universitatsklinikum Gieβen und Marburg GmbH | Axel Hegele | GERMANY | NA | Marburg |
| Universitatsklinikum Koln, Klinik und Poliklinik fur Urologie | Sebastian Wille | GERMANY | NA | Cologne |
| University of Munich, Dept. of urology | Patrick Bastian | GERMANY | NA | Munich |
| Department of Urology | Manfred Wirth | GERMANY | NA | Dresden |
| Evangelisches Krankenhaus Bielefeld gGmbH Akademisches Lehrkrankenhaus der Universitat | Jesco Pfitzenmaier | GERMANY | NA | Bielefeld |
| Martini-Clinic, Prostate Cancer Center | Thomas Steuber | GERMANY | NA | Hamburg |
| Geschaftsfuhrender Oberarzt der Urologischen Klinik Universitasklinikum Mannheim | Christian Bolenz | GERMANY | NA | Mannheim |
| Alexandra General Hospital of Athens, Department of Clinical Therapeutics | eleni Efstathiou | GREECE | NA | Athens |
| General Hospital of Athens Korgialenio-Benakio Greek Red Cross, Urology Clinic | Iraklis Poulias | GREECE | NA | Athens |
| O Agios Savvas Anticancer-Oncology Hospital of Athens, Urology Clinic | ANASTASIOS THANOS | GREECE | NA | Athens |
| Ippokrateio General Hospital of Thessaloniki, Urology Clinic, | Vasileios Papathanasia | GREECE | NA | Thessaloniki |
| University Genral Hospital of Patras, Urology Clinic | Petros Perimenis | GREECE | NA | Patras |
| The Chaim Sheba Medical Center, Oncology Institute | Raanan Berger | ISRAEL | NA | Ramat-Gan |
| The Lady Davis Carmel Medical Center | Avi Stein | ISRAEL | NA | Haifa |
| Asaf Harofeh Medical Center, Oncology Department | Avishay Sella | ISRAEL | NA | Zerifin |
| Tel-Aviv Sourasky Medical Center | Eliahu Gez | ISRAEL | NA | Tel-Aviv |
| Rambam Medical Center, Oncology Institute | Avivit Peer | ISRAEL | NA | Haifa |
| Rabin MC, Institute of Oncology, Davidoff Cancer Center | Eli Rozenbaum | ISRAEL | NA | Petach Tikva |
| Bnai Zion Medical Center | Ofer Nativ | ISRAEL | NA | Haifa |
| Hadassah Hebrew University medical center | Stephen Frank | ISRAEL | NA | Jerusalem |
| Soroka University Medical Center | Wilmosh Mermershtain | ISRAEL | NA | Beer Sheva |
| Azienda Ospedaliera San Camillo Forlanini, Unita Operativa Oncologia Medica | Cora Sternberg | ITALY | NA | Roma |
| Unita Operativa Oncologia Medica, Gruppo di Patologia Uro-Ginecologica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST | Cecelia | ITALY | NA | Meldola |
| Istituto Oncologico Veneto, Unita Operativa di Oncologia Medica I | UMBERTO BASSO | ITALY | NA | Padova |
| Presidio Ospedaliero A. Manzoni, Oncologia Medica | Antonio Ardizzoia | ITALY | NA | Lecco |
| Oncologia Medica Falck, Azienda Ospedaliera Niguarda Ca Granda Azienda Ospedaliera Niguarda Ca Granda | SALVATORE SIENA | ITALY | NA | MILANO |
| Unita Operativa di Urologia, ASL 4 di Teramo, Presidio Ospedaliero G. Mazzini | Carlo Vicentini | ITALY | NA | Teramo |
| Azienda Ospedaliero Universitaria Molinette San Giovanni Battista, S.C. Oncologia Medica 1 | LIBERO CIUFFREDA | ITALY | NA | TORINO |
| Azienda Ospedaliera Istituti Ospitalieri, Struttura Complessa Oncologia - Dipartimento Oncologico | rodolfo passalacqua | ITALY | NA | cremona |
| Azienda USL Ravenna | Giorgio Cruciani | ITALY | NA | Ravenna |
| Azienda Ospedaliera - Ospedale San Carlo Borromeo, Divisione di Oncologia | maria cristina. locatelli | ITALY | NA | Milano |
| Latgalian Urology Center | Olegs Hublarovs | LATVIA | NA | Daugavpils |
| Riga Eastern University Hospital | Arija Brize | LATVIA | NA | Riga |
| Private practice of Dr.Dzintra Litavniece | Dzintra Litavniece | LATVIA | NA | Liepaja |
| Pauls Stradins Clinical University Hospital | Egils Vjaters | LATVIA | NA | Riga |
| Middle East Institute of Health | Dany. Abi Gerges | LEBANON | NA | Bsalim |
| Rafic HARIRI University Hospital | Issam CHEHADE | LEBANON | NA | Beirut |
| American University of Beirut Medical Center | Ali Shamseddine | LEBANON | NA | Beirut |
| Vilnius University Hospital Santariskiu Clinics | Feliksas Jankevicius | LITHUANIA | NA | Vilnius |
| Oncology Institute of Vilnius University, Department of Oncourology | Albertas Ulys | LITHUANIA | NA | Vilnius |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Daimantas Milonas | LITHUANIA | NA | Kaunas |
| St. Elisabeth Ziekenhuis | Paul Kil | NETHERLANDS | NA | Tilburg |
| Martini Ziekenhuis, Polikliniek urologie | Leon Wymenga | NETHERLANDS | NA | Groningen |
| Canisius-Wilhelmina Ziekenhuis | Henk Vergunst | NETHERLANDS | NA | Nijmegen |
| LUMC, Medische Oncologie, | Hans Gelderblom | NETHERLANDS | NA | Leiden |
| Hospital Medic | J. de la Rosette | NETHERLANDS | NA | AMSTERDAM |
| VUMC | R. Van Moorselaar | NETHERLANDS | NA | Amsterdam |
| UMC St Radboud Nijmegen | Peter Mulders | Netherlands | NA | Nijmegen |
| Institute of Oncology | Tomasz Demkow | POLAND | NA | Warszawa |
| NZOZ Centrum Urologiczne Sp. z o.o. | Adam Dobrowolski | POLAND | NA | Myslowice |
| Oddzial Chorob Rozrostowych | Ewa Kalinka-Warzocha | POLAND | NA | Lodz |
| EMC Instytut Medyczny SA | Rafal Kmieciak | POLAND | NA | Wroclaw |
| SP ZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego | Robert Kozlowski | POLAND | NA | Bialystok |
| Wielkopolskie Centrum Onkologii | Piotr Milecki | POLAND | NA | Poznan |
| Niepubliczny Zaklad Opieki Zdrowotnej Avimed Sp. z o.o. | Kamil Bochynek | POLAND | NA | Katowice |
| LexMedica | Zenona Jablonska | POLAND | NA | Wroclaw |
| Oddzial Wewnetrzny III ze Stacja Dializ; Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej | Przemyslaw WIERZBICKI | POLAND | NA | Wolomin |
| SC Oncolab SRL | Dan Lungulescu | ROMANIA | NA | Craiova |
| Fundeni Clinical Institute, Urology Department | Mihai Harza | ROMANIA | NA | Bucharest |
| County Emergency Hospital Sf.Ioan cel Nou | Doina Elena . Ganea | ROMANIA | NA | Suceava |
| Institute of Oncology Prof. Dr. Ion Chiricuta, Oncology Department | Cristina Ligia . Cebotaru | ROMANIA | NA | Cluj-Napoca |
| Institute of Oncology Prof. Dr. Ion Chiricuta, Oncology Department | Tudor Eliade. Ciuleanu | ROMANIA | NA | Cluj Napoca |
| Baia Mare, Emergency County Hospital Dr. Constantin Opris | Dumitru Filip | ROMANIA | NA | BAIA MARE |
| ONCOMED, Medical Oncology | CRISTINA OPREAN | ROMANIA | NA | TIMISOARA |
| PROVITA 2000 Medical Center, Urology Department | Laurentiu Babu | ROMANIA | NA | Constanta |
| Ianuli Medconsult SRL, Medical Oncologym Ground Floor, ap. 1 | Carmen Ianuli | ROMANIA | NA | Bucharest |
| County Hospital | Daniel Iacob | ROMANIA | NA | BRASOV |
| County Hospital | Gabriel Doru. Ghizdavescu | ROMANIA | NA | PLOIESTI |
| Clinical Oncology Dispensary, Oncourology Department | Evgeniy Kopyltsov | RUSSIA | NA | Omsk |
| Altay Regional Oncology Center | Vladimir Lubennikov | RUSSIA | NA | Barnaul |
| Clinic Andros LLC, Urology Department | Alexey Plekhanov | RUSSIA | NA | Saint-Petersburg |
| Leningrad Regional Oncological Dispansery | Khvorostenko | RUSSIA | NA | Saint-Petersburg |
| City Hospital #15, Urology Department, Floor 2 | Vakhtang Shanava | RUSSIA | NA | Saint-Petersburg |
| Republic Clinical Oncology Center, Chemotherapy Department | Sergey Emelyanov | RUSSIA | NA | Izhevsk |
| Regional Clinical Oncology Center | Natalia Rodicheva | RUSSIA | NA | Vladimir |
| Hospital OrKli, Urology Department, Office 20 H | Vladimir Kheifets | RUSSIA | NA | St.Petersburg |
| St.Petersburg Multi-Field City Hospital #2, Department of Urology, 8 floor | Boris Komyakov | RUSSIA | NA | St. Petersburg |
| Russian Oncology Research Center named after N.N. Blokhin, Department of Clinical Pharmacology and Chemotherapy, 22-floor Office #2207 | Avgust Mikhaylovich .Garin | RUSSIA | NA | Moscow |
| Moscow Hertzen Oncology Institute | Boris Alekseev | RUSSIA | NA | Moscow |
| Sverdlovsk Regional Hospital #1 | Alexander Zyirianov | RUSSIA | NA | Ekaterinburg |
| LLC Medical Center Reafan | Marat Zaripov | RUSSIA | NA | Novosibirsk |
| Privatna Urologicka Ambulancia | Roman Sokol | SLOVAKIA | NA | Trencin |
| CUIMED, s.r.o., Urologicka ambulancia | Frederico Goncalves | SLOVAKIA | NA | Bratislava |
| Hospital Clinic i Provincial | begona mellado | SPAIN | NA | Barcelona |
| Corporacio Sanitaria Parc Tauli | Enrique Gallardo | SPAIN | NA | Sabadell |
| Hospital Infanta Sofia | Emilio Rios | SPAIN | NA | San Sebastian de los Reyes |
| Clinica Universitaria de Navarra | JOSE LUIS. PEREZ Gracia | SPAIN | NA | PAMPLONA |
| Hospital Universitario Virgen de la Arrixaca | Isabel. de la Fuente Munoz | SPAIN | NA | El Palmar |
| Hospital Virgen del Rocio | Begona. Perez-Valderrama | SPAIN | NA | Sevilla |
| Hospital Clinico Universitario de Valencia | Isabel Chirivella | SPAIN | NA | Valenica |
| Hospital Universitario Marques de Valdecilla | marta. lopez-brea piqueras | SPAIN | NA | Santander |
| Hospital Vall D′Hebron | Joan CARLES | SPAIN | NA | Barcelona |
| Hospital de la Santa Creu i Sant Pau | Pablo Maroto | SPAIN | NA | Barcelona |
| Hospital Universitario Fundacion Alcorcon | Jesus Garcia-Donas | SPAIN | NA | Alcorcon |
| HCULB | A Saez | Spain | NA | Zaragoza |
| Hospital Universitatario Central de Asturias | Enrique Estrada | Spain | NA | OVIEDO |
| IVO | Eduardo. Solsona Narbona | Spain | NA | Valencia |
| Karolinska Hospital | Sten Nilsson | SWEDEN | NA | Stockholm |
| Urologiska Kliniken | Jan-Erik Damber | SWEDEN | NA | Goteborg |
| Oncology clinic | Claes Ginman | SWEDEN | NA | Karlstad |
| Gazi University Medical Faculty Gazi Hospital | Mustafa Benekli | TURKEY | NA | Ankara |
| Selcuk University Medical Faculty | Serdar Goktas | TURKEY | NA | KONYA |
| Cukurova University Medical Faculty Balcali Hospital | Berksoy Sahin | TURKEY | NA | Adana |
| Istanbul University Cerrahpa？a Medical Faculty Urolgy Department | Obek Can | TURKEY | NA | Istanbul |
| Kharkiv Regional Clinical Center of Urology and Nephrology, Department of Urology #4 | Igor Antonyan | UKRAINE | NA | Kharkiv |
| Ivano-Frankivsk Regional Oncological Dispensary, Oncology Department | Ipolit Kostinskyy | UKRAINE | NA | Ivano-Frankivsk |
| Dnipropetrovsk State Medical Academy, Oncology, Radiodiagnostic and Radiotherapy Chair, City Clinical Hospital #4, 9th Floor | Igor Bondarenko | UKRAINE | NA | Dnipropetrovsk |
| Zaporizhzhya Medical Academy of Postgraduate Education, Urology Dept | Olexiy Lyulko | UKRAINE | NA | Zaporozhye |
| Donetsk Regional Clinical Territorial Medical Association, Department of Urology | Valentyn Kobets | UKRAINE | NA | Donetsk |
| Kyiv City Clinical Hospital #3, Urology Dept. | Petro Ivashchenko | UKRAINE | NA | Kyiv |
| Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov, Urology Department # 2 | Viktor Stus | UKRAINE | NA | Dnepropetrovsk |
| Bukovinian State Medical University | Valerii Zaitsev | UKRAINE | NA | Chernivtsi |
| State Institution of Healthcare, Urology Dept. #3, Kyiv Oleksandrivska Clinical Hospital | Sergii Pasiechnikov | UKRAINE | NA | Kyiv |
| Uzhgorod Central Municipal Clinical Hospital, Municipal Oncological Center | Yevhen Hotko | UKRAINE | NA | Uzhgorod |
| Donetsk Regional Antineoplastic Center, Department of Urology #2 | Andriy Anishchenko | UKRAINE | NA | Donetsk |
| Crimea State Medical University n.a. S. I. Georgievsky, Chair of Oncology | Vitaliy Seferov | UKRAINE | NA | Simferopo |
| Volyn Regional Oncology Dispensary | Orest Andrusenko | UKRAINE | NA | Lutsk |
| State Regional Diagnostics and Treatment Oncology Center | Yaroslav Shparyk | UKRAINE | NA | Lvov |
| Donetsk City Clinical Hospital # 1 | Yuriy Sernyack | UKRAINE | NA | Donetsk |
| Kyiv Regional Clinical Oncology Dispensary, Oncourology department | Golovko | UKRAINE | NA | Kyiv |
| Odesa Regional Clinical Oncology dispensary, Chemotherapy department | Natalya Tavartkiladze | UKRAINE | NA | Odesa |
| Leeds NHS Trust | William Cross | UNITED KINGDOM | NA | Leeds |
| Royal Marsden Hospital | Robert huddart | UNITED KINGDOM | NA | Sutton |
| Mount Vernon Hospital | Peter Hoskin | UNITED KINGDOM | NA | Northwood |
| Oxford Cancer and Haematology Centre | andrew Protheroe | UNITED KINGDOM | NA | Oxford |
| St Richard's Hospital, Dept. of Urology | Paul Carter | UNITED KINGDOM | NA | West Sussex |
| North Lincolnshire & Goole NHS Trust, Scunthorpe General Hospital | Sanjay Dixit | UNITED KINGDOM | NA | Scunthorpe |
| Sarah Cannon Research UK | Simon Chowdhury | UNITED KINGDOM | NA | LONDON |
| University Hospital Birmingham | Nicholas James | UNITED KINGDOM | NA | Birmingham |
| Nottingham City | Santhanam Sundar | UNITED KINGDOM | NA | Nottingham |
| Urology Center of Alabama, PC | George Adams | UNITED STATES | NA | Homewood |
| Huntsman Cancer Institute, University of Utah | Neeraj Agarwal | UNITED STATES | NA | Salt Lake City |
| Associates in Oncology/Hematology, PC | Manish Agrawal | UNITED STATES | NA | Rockville |
| John Theurer Cancer Center at Hackensack University Medical Center | Robert Alter | UNITED STATES | NA | Hackensack |
| Andreou Research | Cal Andreou | CANADA | NA | Surrey |
| Duke Ubniversity Medical Center | Andrew Armstrong | UNITED STATES | NA | Durham |
| Peachtree Hematology-Oncology Consultants | Vasileios Assikis | UNITED STATES | NA | Atlanta |
| Metropolitan Urology, PSC | James Bailen | UNITED STATES | NA | Jeffersonville |
| Newport Pacific Medical Associates Inc. | Neil Barth | UNITED STATES | NA | Newport Beach |
| Urologic Consultants of SE PA | Laurence Belkoff | UNITED STATES | NA | Bala Cynwyd |
| Raleigh Hematology Oncology Associates, P.C. | William Berry | UNITED STATES | NA | Raleigh |
| Pacific Clinical Center | Stanley Brosman | UNITED STATES | NA | Santa Monica |
| The Female/Male Health Centres | Richard Casey | CANADA | NA | Oakville |
| Willamette Valley Cancer Institute and Research Center | John R. Caton | UNITED STATES | NA | Springfield |
| Vanderbilt University Medical Center, Dept. of Urologic Surgery | Sam Chang | UNITED STATES | NA | Nashville |
| PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists | Kevin Chang | UNITED STATES | NA | Oxnard |
| Mid Ohio Oncology/ Hematology, Inc., DBA | Tarek Chidiac | UNITED STATES | NA | Columbus |
| North Idaho Urology | Randil Clark | UNITED STATES | NA | Couer D'Alene |
| Alaska Clinical Research Center, LLC | William R. Clark | UNITED STATES | NA | Anchorage |
| Urology Clinics of North Texas, PA | James Cochran | UNITED STATES | NA | Dallas |
| Arizona Oncology Associates | Christopher DiSimone | UNITED STATES | NA | Tucson |
| The Urological Institute of Northeast New York, CCP | Hugh Fisher | UNITED STATES | NA | Albany |
| Stanley Flax Medical Professional Corporation | Stanley Flax | CANADA | NA | North York |
| Virginia Oncology Associates | Mark Fleming | UNITED STATES | NA | Norfolk |
| Seattle Urology Research Center | Jeffrey Frankel | UNITED STATES | NA | Burien |
| University of Pittsburgh Dept of Urology | Jeff Gingrich | UNITED STATES | NA | Pittsburgh |
| Hudson Valley Urology | Evan Goldfischer | UNITED STATES | NA | Poughkeepsie |
| South Orange County Medical Research Center | Richard Greengold | UNITED STATES | NA | Laguna Hills |
| Midwest Urology/RMD Clinical Research | Richard Harris | UNITED STATES | NA | Melrose Park |
| Texas Oncology Cancer Center-Round Rock | Beth Hellerstedt | UNITED STATES | NA | Round Rock |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Thomas Hutson | UNITED STATES | NA | Dallas |
| Lawrenceville Urology | Gary Karlin | UNITED STATES | NA | Lawrenceville |
| Urological Physicians of S.D. | Danny Keiller | UNITED STATES | NA | San Diego |
| Capitol Comprehensive Cancer Care Clinic | Ali Khojasteh | UNITED STATES | NA | Jefferson City |
| Southern Interior Medical Research Inc. | Thomas Kinahan | CANADA | NA | Kelowna |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA | Mark Kochenderfer | UNITED STATES | NA | Salem |
| Redwood Regional Medical Group | Wes Lee | UNITED STATES | NA | Santa Rosa |
| Brantford Urology Research | Wilson Leung | CANADA | NA | Brantford |
| Hamilton Urology PA | Earle Linder | UNITED STATES | NA | Hamilton |
| Northeast Urology Research | David Lipsitz | UNITED STATES | NA | Concord |
| Mor Urology, Inc. | Morrie Liquornik | CANADA | NA | Newmarket |
| Jeff Marks M.D., P.A. | Jeffrey Marks | UNITED STATES | NA | Plantation |
| Tufts Medical Center | Paul Mathew | UNITED STATES | NA | Boston |
| The Miriam Hospital Office of Clinical Research | Tony Mega | UNITED STATES | NA | Providence |
| Oncology Specialists, S. C Advocate Lutheran General Hospital | Chadi Nabhan | UNITED STATES | NA | Park Ridge |
| Palm Beach Urology Associates, P.A. | Georgis Patsias | UNITED STATES | NA | Wellington |
| Roswell Park Cancer Institute | Roberto Pili | UNITED STATES | NA | Buffalo |
| UROLOGY ENTERPRISES | Ronald Roper | UNITED STATES | NA | MARIETTA |
| Prostate Oncology Specialists | Mark Scholz | UNITED STATES | NA | Marina Del Ray |
| Carolina Urologic Research Center | Neal Shore | UNITED STATES | NA | Myrtle Beach |
| Urological Associates of Lancaster | Paul Sieber | UNITED STATES | NA | Lancaster |
| Virginia Cancer Specialists, PC | Alexander Spira | UNITED STATES | NA | Fairfax |
| Dr. Steinhoff Clinical Research | Gary Steinhoff | CANADA | NA | Victoria |
| Medical Oncology Associates of Augusta, P. C. W. G. Watson Medical Center | Donald Townsend | UNITED STATES | NA | Augusta |
| Comprehensive Cancer Centers of Nevada | Nicholas Vogelzang | UNITED STATES | NA | Las Vegas |
| Idaho Urologic Institute | Joseph Williams | UNITED STATES | NA | Meridian |
| Tweed Cancer Care Centre | Ehtesham Abdi | AUSTRALIA | NA | Tweed Heads, NSW |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 复旦大学附属肿瘤医院伦理委员会 | 同意 | 2012-06-11 |
试验状态信息
试验状态
主动暂停
目标入组人数
国内: 16 人；
国际: 1200 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 15 人 ；
国际: 1245 人；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2012-08-13；
国际：2011-03-24；
试验终止日期
国内：2015-08-07；
国际：2015-08-07；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
