北京PF-06821497片III期临床试验-一项在未使用过针对转移性前列腺癌的新型内分泌治疗或化疗的转移性去势抵抗性前列腺癌男性患者中评估研究用药 PF-06821497 (Mevrometostat) 的研究 (MEVPRO-2)

登记号	CTR20243908	试验状态	进行中
申请人联系人	迟钰力	首次公示信息日期	2024-10-18
申请人名称	Pfizer Inc./ 辉瑞投资有限公司/ Pfizer Inc.; Pfizer Limited

登记号	CTR20243908
相关登记号	暂无
药物名称	PF-06821497片
药物类型	化学药物
临床申请受理号	JXHL2400165/JXHL2400166
适应症	前列腺癌
试验专业题目	一项 PF-06821497 (Mevrometostat) 联合恩扎卢胺治疗转移性去势抵抗性前列腺癌的 III 期、随机、双盲、安慰剂对照研究 (MEVPRO-2)
试验通俗题目	一项在未使用过针对转移性前列腺癌的新型内分泌治疗或化疗的转移性去势抵抗性前列腺癌男性患者中评估研究用药 PF-06821497 (Mevrometostat) 的研究 (MEVPRO-2)
试验方案编号	C2321003	方案最新版本号	FDA最终方案
版本日期:	2024-06-14	方案是否为联合用药	是

申请人名称	[["Pfizer Inc."],["辉瑞投资有限公司"],["Pfizer Inc.; Pfizer Limited"]]
联系人姓名	迟钰力	联系人座机	010-85167287	联系人手机号	18101125283
联系人Email	yuli.chi@pfizer.com	联系人邮政地址	北京市-北京市-东城区朝阳门北大街3号五矿广场B座9层	联系人邮编	100027

主要目的： 证明 PF-06821497 联用恩扎卢胺在延长 rPFS 方面优于安慰剂联用恩扎卢胺。 关键次要： 1. 证明 PF-06821497 联用恩扎卢胺在延长 OS 方面优于安慰剂联用恩扎卢胺。 2. 证明 PF-06821497 联用恩扎卢胺在延长 TTPP 方面优于安慰剂联用恩扎卢胺 其他次要： 1.评估抗肿瘤活性 2.比较治疗组和对照组之间的安全性和耐受性 3.评估 ctDNA 负荷与临床结果之间的相关性 4.评估 PF-06821497 联合恩扎卢胺的 PK 5.比较治疗组和对照组之间的 PRO 探索性： 了解所研究的治疗干预药物与研究参与者疾病生物学之间的关系。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男
健康受试者	无
入选标准	[["筛选时，年龄 ≥ 18 岁（或根据当地法规确定的最低知情同意年龄）的男性研究参与者。"],["依据组织学或细胞学确诊的前列腺腺癌（小细胞特征除外）。对于既往没有组织学诊断的研究参与者，必须使用基线新鲜活检样本来确认诊断。"],["骨扫描结果表明骨骼中有转移病灶，或者 CT/MRI 扫描结果表明软组织中有转移病灶。na. 如果不存在可评估的骨病灶（根据 PCWG3 标准），则需要存在可测量的软组织疾病（根据 RECIST v1.1）。nPET 和 SPECT 不是本研究的可评价影像检查模式。n如果骨扫描显示骨骼中存在强烈对称的骨代谢活性，（称为超级影像），则被视为不可评估。nb. 对于只有可测量的软组织病灶的研究参与者，仅有区域性淋巴结病灶（即主动脉分叉以下的淋巴结病灶）不符合参加研究的资格。"],["通过手术或药物去势，且筛选时血清睾酮水平 ≤ 50 ng/dL (≤ 1.73 nmol/L)。na. 对于尚未接受双侧睾丸切除术的研究参与者，正在使用 GnRH 激动剂或拮抗剂进行雄激素剥夺治疗，此类治疗必须在随机化前至少 4 周开始，且必须在整个研究期间持续进行。n注意：未接受睾丸切除术的参与者也将在研究期间继续接受GnRH（促性腺激素释放激素）激动剂或拮抗剂。"],["在药物或手术去势的情况下，定义疾病进展需满足以下 3 项标准中的 1 项或多项标准：na. PSA 进展定义为至少两次 PSA 水平升高且测定间隔 ≥ 1 周，筛选访视时 PSA 值 ≥ 2 μg/L（如果确认 PSA 升高是唯一的进展指征，则最小起始值为 1 ng/mL）（根据 PCWG-3 标准）；nb. RECIST 1.1 定义的软组织病灶进展。nc. PCWG3 定义的骨病灶进展，在全身放射性核素骨扫描中有 2 处或更多的新转移性骨病灶。"],["在随机化之前，任何既往治疗的急性影响的严重程度必须消退至基线水平或 CTCAE ≤ 1 级（据研究者判定不构成安全性风险的 AE 除外，比如脱发和周围神经病）。"],["ECOG 体力状态评分为 0 或 1，且经研究者评估，预期寿命 ≥ 12 个月。"]]
排除标准	[["可能增加研究参与的风险或（根据研究者判断）可能使研究参与者不适合参加研究的任何医学或精神状况，包括近期（过去一年内）或主动自杀意念/行为或实验室检查异常。na. 除非当地卫生主管部门强制要求，否则不需要进行 HIV/HBV/HCV 检测。nb. 排除已知患有人类免疫缺陷病毒 (HIV)、获得性免疫缺陷综合征 (AIDS) 相关疾病或者活动性乙型肝炎或丙型肝炎的研究参与者。nc. 慢性肝病，包括酒精性肝病、原发性胆汁性肝硬化、原发性硬化性胆管炎、自身免疫性肝炎、Wilson 病、血色素沉着病、α-1 抗胰蛋白酶缺乏症或其他慢性肝病。"],["有临床意义的心血管疾病，定义为：na. 在过去 6 个月内存在以下任何一种情况：心肌梗塞、重度/不稳定型心绞痛、冠状动脉/外周动脉旁路移植术、症状性充血性心力衰竭（纽约心脏病协会心功能 III 或 IV 级）、脑血管意外或症状性肺栓塞或其他有临床意义的血栓栓塞疾病发作、先天性长 QT 综合征、尖端扭转型室速、有重要临床意义的心律失常、左前支半支阻滞（双束支传导阻滞）、NCI CTCAE ≥ 2 级的持续性心律失常、任何等级的房颤。nb. 心脏节律装置/起搏器。植入了心脏节律装置/起搏器的研究参与者必须与申办者医学监查员详细讨论，以确定资格。nc. 筛选 ECG 显示 QTcF ＞ 480 msec。"],["CNS 病理学/神经学结果：na. 已知或疑似脑转移或活跃性软脑膜疾病。nb. 症状性或即将发生的脊髓压迫或马尾神经综合征。nc. 对于患有硬膜外疾病、椎管疾病和既往脊髓受累的研究参与者，如果这些部位已接受治疗、病情稳定且无神经功能损伤，则不排除这些研究参与者。nd. 有具有临床意义的惊厥发作史或任何可能导致惊厥发作的疾病（例如，既往皮质中风、显著的脑损伤）。此外，在随机化前 12 个月内曾出现原因不明的意识丧失或出现短暂性脑缺血发作。"],["任何骨髓增生异常综合征、急性髓系白血病或任何其他既往恶性肿瘤病史，但以下任何情况除外：na. 原位癌或非黑色素瘤皮肤癌。nb. 随机化前 ≥ 3 年发生过任何既往恶性肿瘤，无后续复发或进展证据，不考虑其分期。nc. 随机化前 < 3 年 0 期或 1 期癌症，且研究者评估复发或进展的概率极小。"],["研究参与者必须在 mCRPC 阶段从未接受治疗，例如，研究参与者不能接受过任何细胞毒性化疗（包括但不限于多西他赛），在mCRPC、mCSPC 或非转移性 PC疾病阶段不能接受过 ARSI/醋酸阿比特龙治疗。允许 mCSPC疾病阶段既往接受过多西他赛治疗。na. 如下治疗不被允许使用：恩扎卢胺、阿帕他胺、达罗他胺、醋酸阿比特龙、EZH2 抑制剂或其他全身性治疗（已获批药物或实验性药物）、泼尼松 > 10 mg/天（或等效药物）治疗前列腺癌，但以下情况除外：n○ 使用第一代抗雄激素 (ADT) 药物（例如比卡鲁胺、尼鲁米特和氟他胺）治疗，但随机化前必须有 28 天的洗脱期。n○ 允许mCSPC阶段使用多西他赛治疗，前提是在治疗期间或治疗完成后 3 个月内无治疗失败或疾病进展的征象n○ 针对去势敏感性前列腺癌进行的生物治疗（包括西普鲁塞-T 或放射性核素治疗），前提是在随机化前 28 天或随机化当天停药，并且在该治疗期间或之后未立即出现治疗失败或疾病进展的征象。"],["随机化前 28 天内因原发性前列腺癌或转移相关的疼痛而接受阿片类药物治疗是不被允许的。"],["在本研究所用的研究治疗干预药物首次给药前 30 天（或根据当地要求确定）或 5 个半衰期内（以时间较长者为准）接受过研究性产品（药物或疫苗）给药。"],["当前使用或预期需要使用已知是强效 CYP3A4/5 抑制剂和诱导剂的药物（本研究中的恩扎卢胺除外），具体见第 6.9.1 节和第 6.9.2 节，包括在随机化前 10 天或 5 个半衰期内（以时间较长者为准）的用药。"],["随机化前 14 天内接受重大手术或姑息性局部放射治疗。"],["肾功能不足，定义为 eGFR < 5 mL/min。根据筛选时的研究参与者年龄，使用第 10.7.1 节中推荐的公式计算 eGFR，以确定资格并作为基线用于量化任何后续肾脏安全性事件。n如果基于肾功能估计值进行资格评估，则可以使用筛选和基线 eGFR 值中的较高值。"],["肝功能障碍，定义为：na. 总胆红素 ≥ 1.5 × ULNnb. AST > 2.5 × ULNnc. ALT > 2.5 × ULN"],["血液学异常，定义为：na. ANC < 1500/mm3nb. 血小板 < 100,000/μLnc. 血红蛋白 ≤ 9 g/dL，无论随机化前 14 天内是否输血"],["直接参与研究实施的研究中心工作人员及其家属、受研究者监管的其他研究中心工作人员、直接参与研究实施的申办者和申办者代表员工及其家属。"]]

试验药	[["中文通用名:PF-06821497 英文通用名:PF-06821497 商品名称:NA","剂型:125mg 规格:片剂 用法用量:每日两次口服，每次875mg 用药时程:用药至研究参与者疾病进展且无获益时，或研究者判断不获益"]] 序号 名称 用法
对照药	[["中文通用名:PF-06821497安慰剂 英文通用名:NA 商品名称:NA","剂型:125mg 规格:片剂 用法用量:每日两次口服，每次875mg 用药时程:用药至研究参与者疾病进展且无获益时，或研究者判断不获益"]] 序号 名称 用法

主要终点指标及评价时间

[["根据 RECIST 1.1（软组织疾病）和 PCWG3（骨疾病）确定的经 BICR 评定的 rPFS。","研究结束","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["OS（α 保护）","研究结束","有效性指标"],["TTPP（α 保护）：评估至首次在连续 2 次访视时观察到的 BPI-SF 项目3较基线评分增加 ≥ 2 分或至开始使用短效或长效阿片类药物治疗疼痛的时间","研究结束","有效性指标"],["基线时具有可测量的软组织疾病且获得客观缓解（根据 RECIST 1.1）的研究参与者比例（经 BICR 评定）","研究结束","有效性指标"],["按照 RECIST 1.1 确定的软组织缓解的持续时间（BICR 评定）","研究结束","有效性指标"],["基线时具有可检测 PSA 值的研究参与者中达到 PSA 缓解率 ≥ 50% 的研究参与者比例","研究结束","有效性指标"],["至 PSA 进展时间","研究结束","有效性指标"],["至新抗肿瘤治疗开始的时间","研究结束","有效性指标"],["至细胞毒性化疗开始的时间","研究结束","有效性指标"],["至首起症状性骨事件的时间","研究结束","有效性指标"],["基于单独研究者评估的 PFS2","研究结束","有效性指标"],["AE 以及任何实验室检查和 ECG 异常的类型、发生率、严重程度（根据美国国立癌症研究所不良事件通用术语标准 [NCI CTCAE] v5.0 分级）、严重性以及与研究药物的关系","研究结束","有效性指标+安全性指标"],["基线时和研究中的 ctDNA 负荷","研究结束","有效性指标+安全性指标"],["在选定的访视时间点通过 PF-06821497 给药前血浆谷浓度和给药后血浆浓度表征的 PK","研究结束","有效性指标+安全性指标"],["根据BPI-SF评定的研究参与者报告疼痛症状较基线的变化;第7周期第1天(第25周)BPI-SF项目3(最严重疼痛)较基线的变化.根据FACT-P评定的HRQoL功能和症状较基线的变化","研究结束","有效性指标+安全性指标"],["根据EQ-5D-5L评定的健康状态较基线的变化;根据PRO-CTCAE和FACT-GP5中的项目衡量的症状毒性和总体副作用负荷;根据FACT-P评定的HRQoL和身体健康状况的至明确恶化时间","研究结束","有效性指标+安全性指标"],["对来自基线时、治疗中和/或研究结束时采集的外周血和/或肿瘤组织生物样本分析的生物标志物的测定。","研究结束","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	魏强	学位	硕士	职称	主任医师
	电话	18980601425	Email	wq933@hotmail.com	邮政地址	四川省-成都市-武侯区国学巷37号
	邮编	610041	单位名称	四川大学华西医院

[["四川大学华西医院","魏强","中国","北京市","北京市"],["中国医学科学院肿瘤医院","邢念增","中国","北京市","北京市"],["南京大学医学院附属鼓楼医院","郭宏骞","中国","江苏省","南京市"],["温州医科大学附属第一医院","余志贤","中国","浙江省","温州市"],["华中科技大学同济医学院附属协和医院","章小平","中国","湖北省","武汉市"],["嘉兴市第一医院","何屹","中国","浙江省","嘉兴市"],["上海市同济医院","吴登龙","中国","上海市","上海市"],["浙江大学医学院附属邵逸夫医院","李恭会","中国","浙江省","杭州市"],["北京大学第三医院","张树栋","中国","北京市","北京市"],["皖南医学院弋矶山医院","卓栋","中国","安徽省","芜湖市"],["烟台毓璜顶医院","吴吉涛","中国","山东省","烟台市"],["广州市第一人民医院","韦兴华","中国","广东省","广州市"],["南通市肿瘤医院","王小林","中国","江苏省","南通市"],["宁波大学附属第一医院","蒋军辉","中国","浙江省","宁波市"],["湖南省肿瘤医院","蒋书算","中国","湖南省","长沙市"],["核工业总医院（苏州大学附属第二医院）","薛波新","中国","江苏省","苏州市"],["桂林医学院第二附属医院","高漓","中国","广西壮族自治区","桂林市"],["南京医科大学附属淮安第一医院（淮安市第一人民医院）","傅广波","中国","江苏省","淮安市"],["汕头大学医学院第二附属医院","黎明","中国","广东省","汕头市"],["陕西省人民医院","孙羿","中国","陕西省","西安市"],["福建省肿瘤医院","陈誉","中国","福建省","福州市"],["中国医科大学附属第一医院","孔垂泽","中国","辽宁省","沈阳市"],["山东省立医院","傅强","中国","山东省","济南市"],["河南省肿瘤医院","杨铁军","中国","河南省","郑州市"],["内蒙古自治区人民医院","李三祥","中国","内蒙古自治区","呼和浩特市"],["潍坊市人民医院","孙耀飞","中国","山东省","潍坊市"],["新乡医学院第三附属医院","李军","中国","河南省","新乡市"],["西安交通大学第一附属医院","李磊","中国","陕西省","西安市"],["青岛大学附属医院","牛海涛","中国","山东省","青岛市"],["Multiscan","Dr.Karel Odrazka","捷克共和国","PARDUBICKY KRAJ","Pardubice"],["Fakultni nemocnice Ostrava","Dr.Jaroslav Hajek","捷克共和国","MORAVSKOSLEZSKY KRAJ","Ostrava"],["Fakultni Thomayerova nemocnice","Dr.Eugen Kubala","捷克共和国","PRAHA 4","Prague"],["Urocentrum Praha","Dr.Michaela Matouskova","捷克共和国","PRAHA 2","Praha 2"],["Complex Oncology Center - Stara Zagora, Ltd.","Dr.Tatyana Angelova Todorova-Andreeva","保加利亚","STARA ZAGORA","Stara Zagora"],["Institut Catala d Oncologia - L Hospitalet","Dr.Josep Maria Piulats Rodriguez","西班牙","BARCELONA [BARCELONA]","Barcelona"],["Fred Hutchinson Cancer Center","Dr.Michael Thomas Schweizer","美国","WASHINGTON","Seattle"],["Centre Hospitalier Prive Saint Gregoire","Dr.Aurelien Gobert","法国","NA","Saint Gregoire"],["CIUSSS- saguenay-Lac-Saint-Jean","Dr.Jean-Benoit Paradis","加拿大","QUEBEC","Chicoutimi"],["Complex Oncology Center - Plovdiv EOOD","Dr.Antoaneta Dimitrova Tomova","保加利亚","PLOVDIV","Plovdiv"],["Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD","Dr.Bonka Nikolova Popova","保加利亚","GABROVO","Gabrovo"],["University Multiprofile Hospital for Active Treatment Sofiamed","Dr.Velko Todorov Minchev VTM","保加利亚","SOFIA","Sofia"],["Mid Essex Hospital Services NHS Trust","Dr.Isabella Maund","英国","ESSEX","Chelmsford"],["USA Clinical Trials","Jose De La Cerda III","美国","TEXAS","San Antonio"],["Centro Medico Privado CEMAIC","Dr.Jorge Emilio Salinas","阿根廷","CóRDOBA","CORDOBA"],["CENTRE LEON BERARD","Ms.Aude Flechon","法国","RHONE","Lyon CEDEX 08"],["Canisius-Wilhelmina Ziekenhuis","Diederik Meindert Somford","荷兰","GELDERLAND","Nijmegen"],["Institut de Cancérologie de l`Ouest","Dr.Emmanuelle Bompas","法国","LOIRE-ATLANTIQUE","Saint-Herblain Cedex"],["Medische Centrum Leeuwarden","Dr.Marco Ben Polee","荷兰","FRYSLAN","Leeuwarden"],["Dr.Fabio Leite Couto Fernandez","Hospital de Base de Sao José do Rio Preto","巴西","SAO PAULO","Sao José do Rio Preto"],["Fundacion Instituto Valenciano de Oncología","Maria Jose Juan Fita","西班牙","VALENCIA","Valencia"],["Universitaetsklinikum Tuebingen","Prof.Steffen Rausch","德国","BADEN-WURTTEMBERG","Tubingen"],["Hospital Privado Universitario de Córdoba","Dr.Esteban Metrebian","阿根廷","CóRDOBA","Cordoba"],["National Cancer Center","Jae Young Joung","韩国","KYONGGI-DO","Goyang-si"],["Seoul National University Hospital","Dr.Cheol Kwak","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Hospital Alemao Oswaldo Cruz","Dr.Ariel Galapo Kann","巴西","SAO PAULO","Sao Paulo"],["CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA","Herbert Tavares Palmeira","巴西","CEARA","Fortaleza"],["Centre Hospitalier de l`Université de Montréal","Dr.Fred Saad","加拿大","QUEBEC","Montreal"],["Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d`Auvergne","Dr.Hakim Mahammedi","法国","PUY-DE-DOME","Clermont-Ferrand"],["Institut de cancérologie Strasbourg Europe (ICANS)","Mr.Philippe Barthelemy","法国","BAS-RHIN","Strasbourg"],["Orszagos Onkologiai Intezet","Dr.Lajos Geczi","匈牙利","BUDAPEST","Budapest"],["MICS Centrum Medyczne Torun","Dr.Przemyslaw Adamczyk","波兰","KUJAWSKO-POMORSKIE","Torun"],["Petz Aladar Egyetemi Oktato Korhaz","Dr.Istvan Sipocz","匈牙利","GYOR-MOSON-SOPRON","Gyor"],["Cross Cancer Institute","Dr.Michael Kolinsky","加拿大","ALBERTA","Edmonton"],["Privatna urologicka ambulancia, s.r.o.","Dr.Roman Sokol","斯洛伐克","NA","Trencin"],["Institut Jean Godinot","Dr.Jean-Christophe EYMARD","法国","MARNE","reims"],["Gartnavel General Hospital","Prof.Robert Jones","英国","GLASGOW CITY","Glasgow"],["Royal Blackburn Hospital","Dr.Omi Parikh","英国","LANCASHIRE","Preston"],["The Clatterbridge Cancer Centre","Prof.Isabel Maria Syndikus","英国","WIRRAL","Bebington"],["Athens Medical Center","Dr.Marinos Tsiatas","希腊","ATTIKI","Maroussi"],["Centro Medico Fleischer","Dr.Adriana Maria Menocal","阿根廷","BUENOS AIRES","CABA"],["Liga Norte Riograndense Contra o Cancer","Dr.Andrea Juliana Pereira de Santana Gomes","巴西","RIO GRANDE DO NORTE","Natal"],["Hospital Sao Lucas da PUCRS","Dr.Vinicius Knackfuss Goncalves MR","巴西","RIO GRANDE DO SUL","Porto Alegre"],["IBCC - Instituto Brasileiro de Controle do Cancer","Dr.Felipe José Silva Melo Cruz","巴西","Retrieving data. WaSAO PAULO","Sao Paulo"],["Centro de Urologia (CDU)","Dr.Juan Ignacio Hernandez Moran","阿根廷","CIUDAD AUTóNOMAAIRES","Buenos aires"],["National Cheng Kung University Hospital","Dr.Wen-Pin Su","中国台湾","TAINAN","Tainan"],["Taichung Veterans General Hospital","Dr.Chuan-Shu Chen","中国台湾","TAICHUNG","Taichung"],["Fakultni nemocnice Olomouc","Prof.Bohuslav Melichar","捷克共和国","OLOMOUC","Olomouc"],["Montefiore Medical Center","Dr.Benjamin Gartrell","美国","NEW YORK","Bronx"],["Vanderbilt University Medical Center","Dr.Kelvin A. Moses","美国","TENNESSEE","Nashville"],["Severance Hospital, Yonsei University Health System","Dr.Sang Joon Shin","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Kyungpook National University Chilgok Hospital","Dr.Tae Gyun Kwon.","韩国","TAEGU-KWANGYOKSHI","Daegu"],["Kobe University Hospital","Dr.Hideaki Miyake","日本","HYOGO","Kobe"],["National Cancer Center Hospital East","Dr.Nobuaki Matsubara","日本","CHIBA","Kashiwa"],["Lakeridge Health","Dr.Pawel G. Zalewski","加拿大","ONTARIO","Oshawa"],["Kanazawa University Hospital","Dr.Atsushi Mizokami","日本","ISHIKAWA","Kanazawa"],["University Multiprofile Hospital for Active Treatment – Dr. Georgi Stranski EAD","Dr.Yordan Krasimirov Ignatov","保加利亚","PLEVEN","Pleven"],["CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE","Khabane Tsoeu William Chabane","南非","EASTERN CAPE","Port Elizabeth"],["Keio university hospital","Dr.Takeo Kosaka","日本","TOKYO","Shinjuku-ku"],["Osaka International Cancer Institute","Dr.Masashi Nakayama","日本","OSAKA","Chuo-Ku, Osaka"],["Fundacao Pio XII - Hospital de Cancer de Barretos","Dr.Hadson Silva Araujo","巴西","SAO PAULO","BARRETOS"],["Oulun yliopistollinen sairaala","Dr.Hanna Ronkainen","芬兰","POHJOIS-POHJANMAA","Oulu"],["Helsingin yliopistollinen sairaala","Dr.Antti Rannikko","芬兰","UUSIMAA","Helsinki"],["Clinical Best Solutions","Dr.Pawel Plaza","波兰","LUBELSKIE","Lublin"],["Rigshospitalet","Prof.Gedske Gedske Daugaard","丹麦","HOVEDSTADEN","Kobenhavn"],["Chiba cancer center","Dr.Atsushi Komaru","日本","CHIBA","Chiba"],["Nederlands Kanker Instituut – Antoni van Leeuwenhoek (NKI-AVL)","Dr.Andre Bergman","荷兰","NOORD-HOLLAND","Amsterdam"],["Osaka University Hospital","Dr.Koji Hatano","日本","OSAKA","Suita"],["Asociación de Beneficencia Hospital Sirio Libanés","Dr.Hernan Javier Cutuli","阿根廷","CIUDAD AUTóNOMA DE BUENOS AIRES","Buenos Aires"],["Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest","Mr.Guilhem Roubaud","法国","GIRONDE","Bordeaux"],["Yokosukakyosai","Dr.Kazuki Kobayashi","日本","KANAGAWA","Yokosuka"],["Hospital Universitario 12 de Octubre","Dr.Daniel Ernesto Castellano Gauna","西班牙","MADRID","Madrid"],["National Hospital Organization Shikoku Cancer Center","Dr.Katsuyoshi Hashine","日本","EHIME","Matsuyama"],["Hospital Universitario Fundación Jiménez Díaz","Dr.Imanol Martinez Salas","西班牙","MADRID, COMUNIDAD DE","Madrid"],["Yamagata University Hospital","Prof.Norihiko Tsuchiya","日本","YAMAGATA","Yamagata"],["Centre Hospitalier Régional Universitaire de Brest - Hopital Morvan","Dr.Benjamin Auberger","法国","BRETAGNE","Brest"],["University General Hospital of Larissa","Prof.Athanasios Kotsakis","希腊","THESSALIA","Larissa"],["Hokkaido University Hospital","Dr.Ryuji Matsumoto","日本","HOKKAIDO","Sapporo"],["Krajská nemocnice Liberec","Dr.Igor Richter","捷克共和国","LIBERECKY KRAJ","Liberec"],["4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu","Dr.Beata Freier","波兰","NA","Wroclaw"],["Hokkaido Cancer Center","Dr.Toru Harabayashi","日本","HOKKAIDO","Sapporo"],["Borsod-Abauj-Zemplén Vármegyei Kozponti Kórház és Egyetemi Oktatókórház","Dr.Gergely Dombovari","匈牙利","BORSOD-ABAUJ-ZEMPLEN","Miskolc"],["Kuopion Yliopistollinen Sairaala","Okko Kaariainen","芬兰","POHJOIS-SAVO","Kuopio"],["Asan Medical Center","Prof.In Gab Jeong","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Oncocentro Oncologia","Karine Martins da Trindade Dr","巴西","CEARA","Fortaleza"],["Instituto de Investigaciones Clínicas Mar del Plata","Dr.Ignacio Alfredo Casarini","阿根廷","BUENOS AIRES","Mar del Plata"],["centre hospitalier lyon sud","Dr.Denis Maillet","法国","RHONE","Pierre Benite"],["Universitatsklinikum Munster - Albert Schweitzer Campus","Dr.Martin Boegemann","德国","NORDRHEIN-WESTFALEN","Muenster"],["Vejle Sygehus","Dr.Louise Raunkilde","丹麦","SYDDANMARK","Vejle"],["QEII Health Sciences Centre – Victoria General Site","Dr.Ricardo Rendon","加拿大","NOVA SCOTIA","Halifax"],["Clinique Victor Hugo Le Mans","Dr.Ossama DIDAS","法国","SARTHE","Le Mans"],["Yokohama City University Medical Center","Dr.Hiroji Uemura","日本","KANAGAWA","Yokohama"],["Tampereen yliopistollinen sairaala","Prof.Teemu Johannes Murtola","芬兰","Tampere","PIRKANMAA"],["Franciscus Gasthuis & Vlietland, Locatie Vlietland","Dr.Paul Hamberg","荷兰","ZUID-HOLLAND","Zuid-Holland"],["Dr.Laszlo Landherr","Nograd Varmegyei Szent Lazar Korhaz","匈牙利","NóGRáD","Salgotarjan"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie","DrPawel Jan Wiechno","波兰","MAZOWIECKIE","Warszawa"],["Chonnam National University Hwasun Hospital","Prof. Dr.Dong Deuk Kwon","韩国","JEONRANAMDO","Hwasun-gun"],["Samsung Medical Center","Dr.Seong Soo Jeon","韩国","SEOUL-TEUKBYEOLSI [SEOUL]","Seoul"],["Sodersjukhuset","Dr.Chunde Li","瑞典","STOCKHOLMS LAN [SE-01]","Stockholm"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Dr.Shu-Pin Huang","中国台湾","KAOHSIUNG","Kaohsiung City"],["Royal Derby Hospital","Dr.Prantik Das","中国台湾","DERBYSHIRE","Derby"],["I.E.U. Medical Point Hastanesi","Dr.Cagatay Arslan","土耳其","IZMIR","izmir"],["SBU GULHANE EGITIM VE ARASTIRMA HASTANESI","Dr.Ismail Erturk","土耳其","ANKARA","Ankara"],["Memorial Ankara Hastanesi","Assoc. Prof. Dr.Umut Demirci","土耳其","ANKARA","Ankara"],["Marmara Universitesi Pendik Egitim Arastirma Hastanesi","Dr.Ibrahim Vedat Bayoglu","土耳其","ISTANBUL","Istanbul"],["Ankara Universitesi Tip Fakultesi Hastanesi","Dr.Yuksel Urun urun","土耳其","ANKARA","Ankara"],["Hospital Universitario HM Sanchinarro","Dr.Juan Francisco Rodriguez Moreno","西班牙","MADRID","Madrid"],["National Hospital Organization Kumamoto Medical Center","Dr.Yoshihiro Maeda","日本","KUMAMOTO","Kumamoto"],["Salve Medica Sp. z o.o. Sp. k.","JOLANTA LUNIEWSKA-BURY","波兰","NA","Lodz"],["Carolina Urologic Research Center","Dr.Neal David Shore","美国","SOUTH CAROLINA","Myrtle Beach"],["Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie","Dr.Anna Kowalczyk-Tekiela","波兰","MALOPOLSKIE","Krakow"],["Alexandra General Hospital of Athens","Mr.Michalis Liontos","希腊","ATTIKI","Athens"],["Regionalny Szpital Specjalistyczny im. dr. WIadyslawa Biegańskiego","Dr.Urszula Sadowska","波兰","KUJAWSKO-POMORSKIE","Grudziadz"],["Chungnam national university hospital","Prof.Hyo Jin Lee","韩国","TAEJON-KWANGYOKSHI","Daejeon"],["National Hospital Organization Kyushu Cancer Center","Dr.Takahito Negishi","日本","FUKUOKA","Fukuoka-shi"],["Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie","Mariusz Kwiatkowski","波兰","ZACHODNIOPOMORSKIE","Koszalin"],["T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma","Spec. Dr.Deniz Tural","土耳其","ISTANBUL","Istanbul"],["Centre Oscar Lambret","Dr.Yaovi Eric AMELA","法国","NORD-PAS-DE-CALAIS","Lille"],["Fakultni nemocnice Kralovske Vinohrady","Dr.Jan Dvorak","捷克共和国","PRAHA 10","Praha 10"],["TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi","Prof.Mahmut Gumus","土耳其","ISTANBUL","Istanbul"],["BiaIostockie Centrum Onkologii im. M. SkIodowskiej-Curie w BiaIymstoku","Dr.Kinga Hermanowicz Szamatowicz","波兰","PODLASKIE","Bialystok"],["NextStage Clinical Research-Chicago-(04)","Dr.Amit Raman Patel","美国","ILLINOIS","Lisle"],["Taipei Veterans General Hospital","Dr.Hsiao-Jen Chung","中国台湾","TAIPEI","Taipei"],["Univerzitna nemocnica Martin","Prof.Jan Luptak","斯洛伐克","NA","Martin"],["Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento","Dr.Andrea Zivi","意大利","VENETO","Verona"],["Ospedale San Raffaele","Prof.Andrea Necchi","意大利","MILANO","Milano"],["ISTITUTO ROMAGNOLO PER LO STUDIO DEI TUMORI DINO AMADORI IRCCS IRST SrL","Dr.Giuseppe Schepisi","意大利","FORLI-CESENA","Meldola"],["Turku University Hospital","Peter Bostrom","芬兰","VARSINAIS-SUOMI","Turku"],["Wilgers Oncology Centre","Dr.Petrus Wilhelm van Zijl","南非","GAUTENG","Pretoria"],["Studienpraxis Urologie","Dr. med.Tilman Todenhofer","德国","BADEN-WURTTEMBERG","Nuertingen"],["Arizona Urology Specialists","Dr.Curtis J. Dunshee","美国","ARIZONA","Tucson"],["National & Kapodistrian University of Athens","Prof.Aristotelis Bamias","希腊","ATTIKI","Athens"],["Wits Clinical Research","Rofhiwa Margaret Mathiba RM","南非","GAUTENG","SOWETO"],["APSS- Presidio Ospedaliero S. Chiara","Dr.Orazio Caffo","意大利","TRENTO","Trento"],["Provita Profamilia","Michal Maslowski","波兰","LODZKIE","Piotrków Trybunalski"],["Istituto Clinico Humanitas","Dr.Paolo Andrea Zucali","意大利","MILANO","Rozzano"],["Universitaetsklinikum Hamburg-Eppendorf","Prof.Gunhild Von Amsberg","德国","HAMBURG","Hamburg"],["TASK Eden","Dr.Louis Johannes Botha","南非","WESTERN CAPE","George"],["Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego","Dr.Barbara Radecka","波兰","OPOLSKIE","Opole"],["Azienda Ospedaliera Santa Maria Terni","Dr.Sergio Bracarda","意大利","TERNI","TERNI"],["UNIVERSITY HOSPITAL OF PATRAS","Prof.Angelos Koutras","希腊","ACHAIA","Patras"],["CHRISTUS St. Vincent Regional Cancer Center","Dr.Andrea Teague","美国","NEW MEXICO","SANTA FE"],["St. Helena Hospital","Dr.Tyler Kang","美国","CALIFORNIA","St. Helena"],["Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.","Renata Pacholczak-Madej MD","波兰","MALOPOLSKIE","Kraków"],["Adult & Pediatric Urology, PC","Dr.Andrew Trainer","美国","NE","Omaha"],["Thompson Cancer Survival Center","Dr.David D. Chism","美国","TENNESSEE","Knoxville"],["Highlands Oncology Group","Dr.Joseph Thaddeus Beck","美国","ARKANSAS","Springdale"],["Istituto Nazionale Tumori Regina Elena","Dr.Fabio Calabro","意大利","LAZIO","Mostacciano"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore","Prof.Giampaolo Tortora","意大利","LAZIO","Roma"],["ASST Istituti Ospitalieri di Cremona","Dr.Bruno Perrucci","意大利","NA","Cremona"],["Upstate Urology at Mohawk Valley Health System","Dr.Hanan Goldberg","美国","NEW YORK","Utica"],["Specialty Clinical Research of St. Louis","Gregory Auffenberg","美国","MISSOURI","St. Louis"],["California Cancer Associates for Research and Excellence","Dr.Ravi D. Rao","美国","CALIFORNIA","Fresno"],["First Urology - Jeffersonville","Ryan Malone","美国","IN","Jeffersonville"],["Istituto Nazionale Tumori IRCCS Fondazione Pascale","Dr.Sabrina Rossetti","意大利","CAMPANIA","Napoli"],["Nastved Sygehus","Anne Christensen","丹麦","SJELLAND","Naestved"],["CUIMED, s.r.o., Urologicka ambulancia","Assoc. Prof. Dr.Frederico Manuel Figueiredo Goncalves","斯洛伐克","NA","Bratislava"],["CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia","Dr.Suelen Patricia dos Santos Martins","巴西","SAO PAULO","Sao Paulo"],["Salisbury VA Medical Center","Dr.Michael M. Goodman","美国","NORTH CAROLINA","Salisbury"],["James J Peters VA Medical Center","Glen McWilliams","美国","NEW YORK","Bronx"],["Hospital Nossa Senhora da Conceicao","Dr.Gustavo Vasconcelos Alves","巴西","RIO GRANDE DO SUL","Porto Alegre"],["Skanes Universitetssjukhus Lund","Dr.Olof Staahl","瑞典","SKANE LAN [SE-12]","Lund"],["Auckland City Hospital","Dr.Peter C Fong","新西兰","AUCKLAND","Auckland"],["Waikato Hospital","Dr.Alvin Boon Tee Tan","新西兰","WAIKATO","Hamilton"],["Tauranga Hospital","Jonathan Davis","新西兰","BAY OF PLENTY","Tauranga"],["Fox Chase Cancer Center","Pooja Ghatalia","美国","PENNSYLVANIA","Philadelphia"],["Palo Verde Cancer Specialists","Dr.Amol S. Rakkar","美国","ARIZONA","Glendale"],["Ironwood Cancer & Research Centers","Dr.Joseph Nabong","美国","ARIZONA","Scottsdale"],["Circuit Clinical /Crystal Run Healthcare LLP","Dr.Manuel C. Perry Jr.","美国","NEW YORK","Middletown"],["Los Angeles Hematology Oncology Medical Group","Dr.Ronald Tang","美国","CALIFORNIA","Pasadena"],["Instituto de Educacao, Pesquisa e Gestao em Saude","Dr.Gisele Marinho dos Santos Dr","巴西","RIO DE JANEIRO","Rio de Janeiro"],["Centro de Estudios Clínicos SAGA","Dr.Marcelo Garrido","智利","REGION METROPOLITANA DE SANTIAGO","Santiago, Providencia"],["IC La Serena Research","Dr.Luisa Elena Morales","智利","COQUIMBO","La Serena"],["Oncocentro APYS","Mr.Alejandro Acevedo","智利","VALPARAISO","Vina del Mar"],["Oncovida","Dr.Ariel Osvaldo Zwenger Kloster","智利","REGION METROPOLITANA DE SANTIAGO","Providencia"],["Health New Zealand Te Whatu Ora Waitaha","Dr.David D Gibbs","新西兰","CANTERBURY","Christchurch"],["FALP","Dr.Christian Lorenzo Caglevic","智利","REGION METROPOLITANA DE SANTIAGO","Santiago"],["Clinica Universidad Catolica del Maule","Francisco Ortega","智利","MAULE","Talca"],["Bradfordhill","Dr.Mauricio Burotto","智利","REGION METROPOLITANA DE SANTIAGO","SANTIAGO"],["Centro de Investigacion Clinica del Sur","Mario Alejandro Orio Alvarez","智利","IX REGION","Temuco"],["Bradford Hill Norte","Angela Carolina Estay","智利","ANTOFAGASTA","Antofagasta"],["Urology Clinics of North Texas, PLLC","Dr.Greg Thoreson","美国","TEXAS","Dallas"],["Arkansas Urology","Ralph Henderson","美国","ARKANSAS","Little Rock"],["Medical Oncology Associates of San Diego","Dr.Charles Haskell Redfern","美国","CALIFORNIA","San Diego"],["Northwest Medical Specialties, PLLC","Dr.Mohammed N Kanaan","美国","WASHINGTON","Tacoma"],["Fort Wayne Medical Oncology Hematology","Zhentao Zhang","美国","INDIANA","Fort Wayne"],["Royal Derby Hospital","Dr.Prantik Das","英国","DERBYSHIRE","Derby"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["四川大学华西医院临床试验伦理审查委员会","同意","2024-07-24"],["中国医学科学院肿瘤医院伦理委员会","同意","2024-08-12"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 135 ； 国际: 900 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

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：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；