2022-501493-19-00招募中3 期
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of [177Lu]LU-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer
Curium Pet France, Curium Pet France16 个研究点 分布在 3 个国家目标入组 150 人开始时间: 2022年12月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Time from randomization to radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3) criteria as assessed by blinded independent central review
研究概览
简要总结
To assess the improvement of radiographic progression-free survival (rPFS) in men with mCRPC treated with [177Lu]LU-PSMA-I&T versus patients treated with hormone therapy
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 18 years or older able to understand and provide signed written informed consent
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion.
- •Patients with HBV and HCV may also participate if symptoms are sufficiently managed.
- •ADDITIONAL INCLUSION CRITERIA FOR SUB STUDY: Separate informed consent for participation in the sub-study.
- •ADDITIONAL INCLUSION CRITERIA FOR SUB STUDY: Willing to undergo SPECT: Willing to undergo SPECT/CT imaging at 4 hours, 24 hours, 48 hours, and 7 +/-1 days after 177Lu-PSMA-I&T treatment cycle .
- •ADDITIONAL INCLUSION CRITERIA FOR SUB STUDY: Willing to undergo additional blood sampling for plasma pharmacokinetic measurements.
- •Life expectancy of at least 6 months as assessed by investigator.
- •Willing to initiate ARAT therapy determined by investigator.
- •For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.
- •Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
- •Progressive disease by one or more of the following criteria: a. Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL. b. Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
- •Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). a. Must have received no more than one previous AR-directed therapy. b. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castrationresistant setting. c. Must have progressed while on ARAT.
- •PSMA-PET scan (e.g. 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
- •Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration
排除标准
- •Prior treatment with radioligand therapy including other lutetium-labeled compounds.
- •Previous use of G-CSF for persistent neutropenia after standard of care treatment.
- •Participants with active Covid
- •Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours).
- •Prior treatment with radium-223 (Xofigo) within the past 12 weeks.
- •Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted as long as no more than 6 doses were received, the last dose was administered >1 year prior to consent and disease progression did not occur during docetaxel treatment.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
- •Patients with known HRR gene-mutation (BRCA 1/2 encompassing both germline and somatic) who have not been previously treated with olaparib or rucaparib.
- •Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- •Inadequate organ and bone marrow function as evidenced by: a. Hemoglobin < 8 g/dL. b. Absolute neutrophil count < 1.5 x 109/L. c. Platelet count < 100 x 109/L. d. AST/SGOT and/or ALT/SGPT > 3.0 x ULN. e. Total bilirubin > 2 x ULN unless patient has known Gilbert’s syndrome and then may be 3 x ULN. f. Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation. g. Albumin < 2.75 g/dL
- •Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded.
- •Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
- •Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period.
- •ADDITIONAL EXCLUSION CRITERIA FOR SUB STUDY: Unable to undergo SPECT/CT imaging as required in the sub-study protocol.
- •Known central nervous system (CNS) metastasis unless received therapy, asymptomatic and neurologically stable.
- •Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization.
- •Major surgery within 30 days of randomization as determined by the Investigator.
- •Patients with active significant cardiac disease defined by any of the following: a. New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the Informed Consent Form (ICF) unless treated with improvement. b. Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias c. History of long QT syndrome or know history of Torsades de Pointe d. History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature
- •Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression
- •Patients with a superscan seen on baseline bone scan as determined by investigator.
- •Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer
结局指标
主要结局
Time from randomization to radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3) criteria as assessed by blinded independent central review
Time from randomization to radiographic progression as determined by Prostate Cancer Working Group 3 (PCWG3) criteria as assessed by blinded independent central review
次要结局
- Time from randomization to death by any cause
- Time from randomization to the second radiographic progression as determined by PCWG3 or RECIST 1.1 by Blinded Independent Central Review (BICR) after crossover
- Time from randomization to progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator.
- Time from randomization to the second progression (PFS, composite) based on the following events, whichever occurs first: PCWG3 or RECIST progression, clinical/symptomatic progression and/or pain progression, or death due to any cause as determined by investigator.
- PSA50 response rate, defined as a confirmed reduction of PSA from baseline of ≥ 50%
- Time from randomization to first symptomatic skeletal event (SSE-free survival)
- Time from randomization to radiographic soft tissue progression (rSTP) as measured by RECIST 1.1 by BICR.
- Time from randomization to first use of chemotherapy
- Quality of Life improvement based on EORTC QLQ-C30 questionnaire
研究者
Clinical Development Lead
Scientific
Curium Pet France
研究点 (16)
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