ACTRN12622001378718招募中1 期
Phase I/IIa Dose Escalation and Toxicity Study of [212Pb]Pb-ADVC001 in Metastatic Prostate Adenocarcinoma (TheraPb – Phase I/II)
AdvanCell Isotopes Pty Ltd0 个研究点目标入组 18 人开始时间: 2022年10月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Male aged 18 years or older with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma or metastatic disease typical of prostate cancer (i.e. Involving bone or pelvic lymph nodes or para-aortic lymph nodes)
- •Patients with castration-resistant prostate cancer that have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapy unless considered contraindicated by a medical oncologist or patient declines treatment
- •Progressive disease with rising PSA level, or new lesion(s) in the viscera or lymph nodes as per RECIST 1.1 or in bone as per Prostate Cancer Working Group 3
- •Significant PSMA avidity on [68Ga]Ga-PSMA PET/CT
- •ECOG Performance status 0 to 2
- •Adequate renal, bone and liver function (Absolute neutrophil count: greater than or equal to 2 x 109 /L , Hemoglobin: greater than or equal to 90 g/L, Platelet count: greater than or equal to 150,000 x 109/L, Serum creatinine: less than 1.5 x upper limit of normal (ULN) i.e = 125 umol/L or calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 by Cockcroft-Gault formula, Serum total bilirubin: less than 1.5 x ULN (unless the patient has Gilbert's syndrome in which case direct bilirubin must be normal), Serum AST and ALT: less than 1.5 x ULN in the absence of liver metastases; less than 3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria)
- •Estimated life expectancy greater than 12 weeks
- •Willing and able to comply with all study requirements, including the timing and nature of all required assessments (i.e. blood testing and scanning.)
- •Have provided written Informed Consent for participation in this trial
排除标准
- •Prostate cancer with known significant sarcomatoid or spindle cell or neuroendocrine small cell components
- •Sjogren’s syndrome
- •ECOG status >2
- •Prior treatment with radioligand therapy
- •Contraindications to the use of corticosteroid treatment
- •Active malignancy other than prostate cancer (excluding non-melanomatous skin cancers)
- •Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
- •Severe claustrophobia that may impact the participants ability to comply with all aspects of the imaging protocol
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