此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (VECTRA-01)

2026年8月24日 更新者：AstraZeneca

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Approximately 670 adult participants with mCRPC will be randomized to receive either AZD2265 or standard of care treatment (investigator's choice of cabazitaxel, ARPI, or radium-223). They will receive their assigned treatment until disease progression, unacceptable toxicity, or other discontinuation criteria are met. Tumor evaluation scans will continue after treatment discontinuation until radiographically confirmed progression or death.

All patients will be followed for survival until the end of the study. An Independent Data Monitoring Committee (IDMC) composed of independent experts will be convened to monitor the safety and scientific integrity of the study.

研究类型

介入性

注册 (估计的)

670

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、100142
        • 尚未招聘
        • Research Site
      • Beijing、中国、100034
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610041
        • 尚未招聘
        • Research Site
      • Chongqing、中国、400030
        • 尚未招聘
        • Research Site
      • Fuzhou、中国、350005
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510060
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510630
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510120
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310022
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310003
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310014
        • 尚未招聘
        • Research Site
      • Jinan、中国、250117
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210006
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210029
        • 暂停
        • Research Site
      • Shanghai、中国、200032
        • 尚未招聘
        • Research Site
      • Shanghai、中国、200025
        • 尚未招聘
        • Research Site
      • Shenyang、中国、110001
        • 尚未招聘
        • Research Site
      • Wuhan、中国、430022
        • 尚未招聘
        • Research Site
      • Wuhan、中国、430030
        • 尚未招聘
        • Research Site
      • Xi'an、中国、710061
        • 尚未招聘
        • Research Site
  • 以色列
      • Haifa、以色列、3109601
        • 尚未招聘
        • Research Site
      • Jerusalem、以色列、00000
        • 尚未招聘
        • Research Site
      • Petah Tikva、以色列、4941492
        • 尚未招聘
        • Research Site
      • Ramat Gan、以色列、52621
        • 尚未招聘
        • Research Site
      • Tel Aviv、以色列、64239
        • 尚未招聘
        • Research Site
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • 尚未招聘
        • Research Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大、B3H 1V7
        • 尚未招聘
        • Research Site
    • Ontario
      • Hamilton、Ontario、加拿大、L8V 1C3
        • 尚未招聘
        • Research Site
      • Toronto、Ontario、加拿大、M4N 3M5
        • 尚未招聘
        • Research Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • 尚未招聘
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • 招聘中
        • Research Site
      • Montreal、Quebec、加拿大、H3A 1A1
        • 尚未招聘
        • Research Site
  • 印度
      • Bangalore、印度、560017
        • 尚未招聘
        • Research Site
      • Gurgaon、印度、122002
        • 尚未招聘
        • Research Site
      • Gurgaon、印度、122001
        • 尚未招聘
        • Research Site
      • Navi Mumbai、印度、410210
        • 尚未招聘
        • Research Site
  • 台湾
      • Kaohsiung City、台湾、833401
        • 尚未招聘
        • Research Site
      • Taipei、台湾、11259
        • 尚未招聘
        • Research Site
      • Taipei、台湾、10002
        • 尚未招聘
        • Research Site
      • Taipei、台湾、11217
        • 尚未招聘
        • Research Site
      • Taoyuan、台湾、333
        • 尚未招聘
        • Research Site
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06530
        • 尚未招聘
        • Research Site
      • Ankara、土耳其（türkiye）、06620
        • 尚未招聘
        • Research Site
      • Istanbul、土耳其（türkiye）、34098
        • 尚未招聘
        • Research Site
      • Istanbul、土耳其（türkiye）、34752
        • 尚未招聘
        • Research Site
  • 奥地利
      • Linz、奥地利、4020
        • 尚未招聘
        • Research Site
      • Salzburg、奥地利、5020
        • 尚未招聘
        • Research Site
  • 巴西
      • São Paulo、巴西、05652-900
        • 尚未招聘
        • Research Site
      • São Paulo、巴西、01308-050
        • 尚未招聘
        • Research Site
  • 德国
      • Augsburg、德国、86156
        • 尚未招聘
        • Research Site
      • Berlin、德国、13353
        • 尚未招聘
        • Research Site
      • Bonn、德国、53127
        • 尚未招聘
        • Research Site
      • Cologne、德国、50937
        • 尚未招聘
        • Research Site
      • Dresden、德国、01307
        • 尚未招聘
        • Research Site
      • Essen、德国、45122
        • 尚未招聘
        • Research Site
      • Jena、德国、07747
        • 尚未招聘
        • Research Site
      • Karlsruhe、德国、76133
        • 撤销
        • Research Site
      • München、德国、81675
        • 尚未招聘
        • Research Site
      • Münster、德国、48149
        • 尚未招聘
        • Research Site
      • Nuremberg、德国、90419
        • 撤销
        • Research Site
      • Rostock、德国、18057
        • 尚未招聘
        • Research Site
      • Stuttgart、德国、70174
        • 尚未招聘
        • Research Site
      • Tübingen、德国、72076
        • 尚未招聘
        • Research Site
      • Würzburg、德国、97080
        • 尚未招聘
        • Research Site
  • 日本
      • Chiba、日本、260-8717
        • 尚未招聘
        • Research Site
      • Chūōku、日本、104-0045
        • 尚未招聘
        • Research Site
      • Fukuoka、日本、812-8582
        • 招聘中
        • Research Site
      • Hamamatsu、日本、431-3192
        • 尚未招聘
        • Research Site
      • Kamakura-shi、日本、247-8533
        • 尚未招聘
        • Research Site
      • Kanazawa、日本、920-8641
        • 招聘中
        • Research Site
      • Kashiwa、日本、227-8577
        • 尚未招聘
        • Research Site
      • Kobe、日本、650-0047
        • 尚未招聘
        • Research Site
      • Kyoto、日本、606-8507
        • 尚未招聘
        • Research Site
      • Sapporo、日本、060-8638
        • 招聘中
        • Research Site
      • Suita-shi、日本、565-0871
        • 尚未招聘
        • Research Site
      • Yokohama、日本、236-0004
        • 尚未招聘
        • Research Site
  • 法国
      • Villejuif、法国、94800
        • 尚未招聘
        • Research Site
  • 波兰
      • Gdansk、波兰、80-214
        • 尚未招聘
        • Research Site
      • Krakow、波兰、31-501
        • 尚未招聘
        • Research Site
      • Warsaw、波兰、02-781
        • 尚未招聘
        • Research Site
  • 泰国
      • Bangkok、泰国、10700
        • 尚未招聘
        • Research Site
      • Bangkok、泰国、10210
        • 尚未招聘
        • Research Site
  • 澳大利亚
      • Darlinghurst、澳大利亚、2010
        • 尚未招聘
        • Research Site
      • Kurralta Park、澳大利亚、5037
        • 尚未招聘
        • Research Site
      • Melbourne、澳大利亚、3000
        • 尚未招聘
        • Research Site
      • Murdoch、澳大利亚、WA6150
        • 尚未招聘
        • Research Site
  • 瑞典
      • Stockholm、瑞典、17176
        • 尚未招聘
        • Research Site
      • Umeå、瑞典、901 85
        • 尚未招聘
        • Research Site
  • 美国
    • Alabama
      • Dothan、Alabama、美国、36303
        • 招聘中
        • Research Site
    • Arizona
      • Phoenix、Arizona、美国、85004
        • 尚未招聘
        • Research Site
    • California
      • Duarte、California、美国、91010
        • 尚未招聘
        • Research Site
      • Irvine、California、美国、92618
        • 尚未招聘
        • Research Site
      • Newport Beach、California、美国、92660
        • 招聘中
        • Research Site
      • San Francisco、California、美国、94143
        • 尚未招聘
        • Research Site
    • Colorado
      • Aurora、Colorado、美国、80045
        • 尚未招聘
        • Research Site
    • Florida
      • Miami、Florida、美国、33165
        • 招聘中
        • Research Site
    • Illinois
      • O'Fallon、Illinois、美国、62269
        • 尚未招聘
        • Research Site
    • Louisiana
      • Metairie、Louisiana、美国、70006
        • 招聘中
        • Research Site
    • Michigan
      • Detroit、Michigan、美国、48201
        • 撤销
        • Research Site
      • Grand Rapids、Michigan、美国、49503
        • 尚未招聘
        • Research Site
    • Missouri
      • St Louis、Missouri、美国、63104
        • 尚未招聘
        • Research Site
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • 招聘中
        • Research Site
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • 尚未招聘
        • Research Site
    • New York
      • New Hyde Park、New York、美国、11042
        • 尚未招聘
        • Research Site
      • New York、New York、美国、10065
        • 尚未招聘
        • Research Site
    • Ohio
      • Cleveland、Ohio、美国、44195
        • 尚未招聘
        • Research Site
      • Dayton、Ohio、美国、45415
        • 尚未招聘
        • Research Site
    • Oregon
      • Portland、Oregon、美国、97239
        • 尚未招聘
        • Research Site
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • 尚未招聘
        • Research Site
    • South Carolina
      • Myrtle Beach、South Carolina、美国、29572
        • 尚未招聘
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 尚未招聘
        • Research Site
    • Texas
      • Houston、Texas、美国、77042
        • 招聘中
        • Research Site
    • Utah
      • Salt Lake City、Utah、美国、84106
        • 尚未招聘
        • Research Site
    • Washington
      • Tacoma、Washington、美国、98405
        • 尚未招聘
        • Research Site
  • 芬兰
      • Kuopio、芬兰、70210
        • 尚未招聘
        • Research Site
  • 英国
      • London、英国、EC1A 7BE
        • 尚未招聘
        • Research Site
      • Middlesbrough、英国、TS4 3BW
        • 尚未招聘
        • Research Site
      • Southampton、英国、SO16 6YD
        • 尚未招聘
        • Research Site
      • Truro、英国、TR1 3LJ
        • 尚未招聘
        • Research Site
  • 西班牙
      • Barcelona、西班牙、8035
        • 尚未招聘
        • Research Site
      • Barcelona、西班牙、08025
        • 尚未招聘
        • Research Site
      • L'Hospitalet de Llobregat、西班牙、08908
        • 尚未招聘
        • Research Site
      • Madrid、西班牙、28041
        • 尚未招聘
        • Research Site
      • Majadahonda、西班牙、28222
        • 尚未招聘
        • Research Site
      • Málaga、西班牙、29009
        • 尚未招聘
        • Research Site
      • Santiago de Compostela、西班牙、15706
        • 尚未招聘
        • Research Site
  • 韩国
      • Goyang-si、韩国、10408
        • 尚未招聘
        • Research Site
      • Seoul、韩国、3722
        • 尚未招聘
        • Research Site
      • Seoul、韩国、03080
        • 尚未招聘
        • Research Site
      • Seoul、韩国、06591
        • 尚未招聘
        • Research Site
      • Seoul、韩国、5505
        • 尚未招聘
        • Research Site
      • Seoul、韩国、6351
        • 尚未招聘
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • ≥ 18 years of age.
  • Diagnosis of adenocarcinoma of prostate.
  • Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
  • Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
  • Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
  • Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.
  • Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).
  • Positive PSMA PET/CT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).
  • ECOG performance status of 0 to 2.
  • Adequate organ and bone marrow function as described in study protocol.
  • Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
  • Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.

Exclusion Criteria:

  • Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
  • Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.
  • Receipt of > 6 cycles of PSMA-directed β-emitting therapeutic RC.
  • History of another primary malignancy, with exceptions.
  • Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
  • Clinically significant ECG abnormalities, with exceptions.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
药品：Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
IV
其他名称：
  • AZD2265, FPI-2265
有源比较器：Arm B
Investigator's choice of cabazitaxel, ARPI, or radium-223
药品：恩杂鲁胺
口服
其他名称：
  • 新坦迪
药品：Cabazitaxel
IV in combination with oral prednisone/prednisolone
其他名称：
  • 耶夫塔娜
药品：Abiraterone
Oral in combination with prednisone/prednisolone
其他名称：
  • 紫蒂加
药品：Radium-223
IV
其他名称：
  • 飞哥
药品：Apalutamide
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
其他名称：
  • 埃利阿达
药品：Darolutamide
Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
其他名称：
  • 努贝卡
药品：Deutenzalutamide
Oral; available in China only

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Radiographic Progression-Free Survival (rPFS)
大体时间：From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.
From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)
Overall Survival (OS)
大体时间：From randomization until death from any cause (up to approximately 33 months)
OS is defined as the length of time from randomisation until the date of death due to any cause.
From randomization until death from any cause (up to approximately 33 months)

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS)
大体时间：From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
PFS is defined as the time from randomisation to the earliest of progression (defined as radiographic progression assessed by BICR per RECIST 1.1 and/or PCWG3 criteria, clinical progression, or PSA progression), or death due to any cause.
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
大体时间：From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving a >= 50% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
大体时间：From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Proportion of participants achieving >=90% decrease in PSA from baseline.
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Duration of Response (DoR)
大体时间：From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone) as determined by BICR or death in the absence of disease progression.
From first documented response until progression per RECIST 1.1/PCWG3 by BICR, or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Symptomatic Skeletal Event-Free Survival (SSE-FS)
大体时间：From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)

SSE-FS is defined as the time from randomisation to the earliest of the following:

  • Use of radiation therapy to prevent or relieve skeletal symptoms.
  • Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
  • Occurrence of spinal cord compression.
  • Orthopaedic surgical intervention for bone metastasis.
  • Death due to any cause.
From randomization until first symptomatic skeletal event or death from any cause, whichever occurs first (up to approximately 33 months)
Plasma concentrations of AZD2265
大体时间：Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Plasma concentrations of AZD2265 pre-dose and post-dose.
Pre-dose and post-dose on Day 1 of Cycles 1 and 2; 3-24 hours post-dose on Cycle 1 Day 1 only (up to approximately 7 weeks)
Objective Response Rate (ORR)
大体时间：From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)
ORR is defined as the proportion of participants with measurable soft tissue disease at baseline who have a CR or PR as determined by BICR, per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone).
From baseline; assessed by BICR per RECIST 1.1/PCWG3 every 8 weeks for first 32 weeks, then every 12 weeks until radiographic progression (up to approximately 33 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月4日

初级完成 (估计的)

2029年6月4日

研究完成 (估计的)

2030年6月6日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D9735C00001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅