NCT06850545招募中不适用
Kuopio Lutetium-177 Study in Patients with PSMA-Positive Metastatic Prostate Cancer
Kuopio University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
KuPSMALu-trial is an observational study for patients treated with 177LuPSMA-I&T in Kuopio University Hospital, Finland. Study focuses on efficacy, safety and biomarker research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The patient must sign informed consent to participate in the study.
- •Patients must be over 18 years of age.
- •Patients must have histologically confirmed metastatic prostate adenocarcinoma. Histological samples may show neuroendocrine features, but the primary component must be adenocarcinoma.
- •Patients must have metastatic castration-resistant prostate cancer (mCRPC) that has been treated with at least docetaxel and abiraterone or enzalutamide, or the patients must have declined chemotherapy or be ineligible for docetaxel-based chemotherapy due to contraindications.
- •Patients must have an adequate performance status: WHO 0-
- •Castration must have been achieved either chemically (LHRH analog or antagonist) or surgically (orchiectomy). Castration is defined as a low testosterone level (S-testosterone ≤ 1.7 mmol/l).
- •Patients must have PSMA-positive tumor burden detected by 18F-PSMA-PET-CT imaging.
- •Patients must have adequate renal and liver function (Creatinine < 2x upper limit of normal (ULN), ALT and ALP < 5x ULN).
- •Patients' blood counts must be within acceptable levels (Hb ≥ 100 g/l, Platelets ≥ 100 x 10⁹/L, Leukocytes ≥ 3.0 x 10⁹/L, or Neutrophils ≥ 1.0 x 10⁹/L).
- •The expected survival must be more than 6 months.
- •Patients with ejaculatory capacity must commit to not donating sperm during the treatments and for 6 months after treatment completion.
排除标准
- •Patients whose physical condition and cooperation are insufficient to follow the given instructions.
- •Patients who do not meet the criteria mentioned in the inclusion criteria.
- •Patients must not have PSMA-negative tumor burden in the liver. The amount of PSMA-negative tumor burden must not exceed the amount of PSMA-positive tumor burden.
- •Patients with symptomatic untreated spinal cord compression.
- •Patients must not have acute hydronephrosis or urinary tract obstruction.
- •Patients must not have a recurrent infection that impairs functional capacity.
结局指标
主要结局
Overall survival
时间窗: 5 years
Overall survival in the trial
次要结局
- PSA decrease of 50% or more(36 weeks)
- Adverse Events(36 weeks)
研究者
Okko Kääriäinen
Clinical oncologist
Kuopio University Hospital
研究点 (1)
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