EUCTR2018-003652-21-IT进行中（未招募）1 期
Interventional two arms open-label study for evaluating the diagnostic performance of PET PSMA in patients affected by biochemical recurrent prostate cancer. - PSMA-2018
OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO0 个研究点目标入组 894 人开始时间: 2021年1月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 894
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Histological confirmation of prostate malignancy.
- •2.Patient must have had their primary tumor treated with surgery and/or radiation and salvage radiation to the prostate bed or pelvis is allowed.
- •3.Patient must be = 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
- •4.Patient must have an Eastern Cooperative Oncology Group performance status = 2.
- •5.Diagnosis of biochemical failure:
- •For patients treated with surgery: arise of PSA = 0.2 ng/ml.
- •For patients treated with radical RT: PSA level +2 ng/ml from nadir.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 358
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 536
排除标准
- •1.More than 3 years of ADT, with the most recent ADT treatment having occurred < 6 months prior to enrollment.
- •2.Spinal cord compression or impending spinal cord compression.
- •3.Receipt of any other investigational agents in the previous 3 months
- •4.Inability to lie flat during or tolerate PET/CT.
- •5.Refusal to sign informed consent
- •6.Participation in a concurrent clinical trial.
研究者
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