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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 670
- 试验地点
- 104
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •≥ 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
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Apalutamide (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Darolutamide (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Cabazitaxel (Drug)
Arm A
AZD2265
干预措施: AZD2265 (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Enzalutamide (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Abiraterone (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Radium-223 (Drug)
Arm B
Investigator's choice of cabazitaxel, ARPI switch, or radium-223
干预措施: Rezvilutamide (Drug)
结局指标
主要结局
未指定
次要结局
- Objective Response Rate (ORR)(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))