Prospective Pilot Clinical Trial of Ac225-PSMA Radioligand Therapy of Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 主要终点
- serum PSA level
研究概览
简要总结
The death of prostate cancer patients is mainly due to metastatic castration-resistant prostate cancer. Though some new therapies has been tried to prolong the life-span of mCRPC patients, a dilemma was encountered for the drug-resistance. The PSMA RLT has been tested its efficacy and safety for the therapy of these patients. In our clinical trial, a new PSMA ligand will been used to be labeled with Ac225. This will be a prospective pilot clinical trial. 20 mCRPC patients who was incapable of 2rd ADT or chemotherapy will be recruited in this clinical tiral. The efficacy and safety of 225Ac-PSMA will be evaluated after the administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed prostatic adenocarcinoma.
- •Clinically or imaging confirmed metastatic castration resistant prostate cancer.
- •Conventional treatment failure or not available.
- •PSMA avid of lesions confirmed by PSMA PET/CT.
- •Hematopoietic function, kidney and liver function is normal.
- •Can follow the study plan and can timely follow-up.
- •Agree to sign the informed consent.
排除标准
- •Pathological types other than the prostatic adenocarcinoma of prostate cancer.
- •Not PSMA avid of lesions confirmed by PSMA PET/CT.
- •Concurrent with other uncontrolled malignant tumours or five years, except for carcinoma in situ.
- •Concomitant diseases are not suitable for radioactive therapy.
- •Other conditions (religion, psychology, etc.) affect the informed consent, research plan, or not compliant of follow-up schedule.
研究组 & 干预措施
mCRPC for PSMA RLT
225Ac-PSMA 100KBq/kg, iv. Totally 2 doses, every 8 weeks.
干预措施: 225Ac-PSMA (Drug)
结局指标
主要结局
serum PSA level
时间窗: through study completion, an average of 1 year
Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease \> 50%, 30% \~ 50% and \< 30%.
次要结局
- Adverse Events and Serious Adverse Events(through study completion, an average of 1 year.)