NCT04663997进行中（未招募）2 期
A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Progression-free survival
研究概览
简要总结
177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment
详细描述
The standard or usual treatment for this disease is a chemotherapy drug called docetaxel, given by intravenous every 3 weeks, for up to 12 treatments.
177Lu-PSMA-617 is a new type of therapy for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. 177Lu-PSMA-617 has been shown to shrink tumours in animals and has been studied in limited numbers of men with prostate cancer and seems promising but it is not clear if it can offer better control of prostate cancer compared to docetaxel chemotherapy .
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
- None
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
- •Histological evidence of prostate cancer with no evidence of small cell component
- •Patients must have castration resistance and metastatic disease with evidence of biochemical or imaging progression in the setting of surgical/medical castration
- •Progression on treatment with abiraterone and/or enzalutamide, or similar next-generation androgen receptor (AR) targeted therapy
- •Evidence of PSMA positive metastatic disease, as assessed on PSMA-PET imaging studies obtained as part of other clinical trial protocols are mandated, provided they are obtained within a timeframe that meets the requirements of this study. The radiopharmaceuticals must be based on a lysine-urea-glutamate backbone, with a 18F or 68Ga radionuclide label.
- •Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone < 1.7 nmol/L
- •Adequate organ function
- •Recover from all previous cancer treatment toxicities to grade ≤ 2 (as per CTCAE v5.0)
- •Male subject ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
排除标准
- •Prior treatment with chemotherapy for castration-resistant disease or prior chemotherapy in the castration-sensitive (hormone-sensitive) setting ≤ 1 year prior to enrollment.
- •Prior treatment with 177Lu-PSMA (including other radiolabeled therapeutic PSMA-ligands) or radio-immunotherapy. Prior treatment with radium-223 is allowed but requires a minimum of a 6-month interval between the last dose of radium-223 and enrollment.
- •Radiotherapy to target lesions (measurable disease) ≤ 12 weeks prior to enrolment.
- •Presence of majority (> 50% of extra-osseous lesions) or large (> 5 cm) soft tissue lesions that are negative on PSMA-Ligand PET/CT or PSMA-Ligand PET/MR
- •Known parenchymal brain metastases
- •Active epidural disease (treated epidural disease is permitted)
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Clinically significant cardiac disease
- •Major surgery within 4 weeks of starting study treatment
- •Patients with a history of hypersensitivity to the study drug or components
- •Patients with a clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or sever psychiatric illness/social situations.
研究组 & 干预措施
177 Lu-PSMA-617
Experimental
干预措施: 177Lu-PSMA-617 (Drug)
Docetaxel
Active Comparator
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
次要结局
- Progression-free survival rate at 6 months defined by RECIST 1.1(6 months)
- Progression-free survival rate at 6 months defined by PSA(6 months)
- Progression-free survival rate at 6 months defined by PCWG 3(6 months)
- Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy(3 years)
- Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).(3 years)
- Time to commencement of third line therapy(3 years)
- Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1)(3 years)
- Overall Survival(3 years)
- Proportions of patients with decreased PSA from baseline and the magnitude of change(3 years)
- Adverse event (AE) profile (CTCAE v5.0)(3 years)
研究者
研究点 (10)
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