EUCTR2018-004458-14-IT进行中(未招募)1 期
Phase III clinical trial Oligometastatic and Oligorecurrent PROstate Cancer: enhancing patients’ selection by new ImagiNG biomarkers - PROvING
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 246
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
- •Related to PCa:
- •1. Histologically documented castration resistant PCa treated with radical prostatectomy or loco-regional EBRT.
- •2. BCR PCa demonstrated by two consecutive PSA determinations
- •3. Life expectancy of more than 6 months.
- •Related to the patient:
- •4. Male patients aged >18 years without upper age limit.
- •5. Ability to understand and willingness to sign a written informed consent document.
- •6. Written informed consent obtained according to international guidelines and local laws.
- •7. Compliant to the study procedures, based on the Investigator point of view.
- •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 61
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 185
排除标准
- •Related to the PCa
- •1. Other malignancies
- •Related to the patient:
- •1. Patient not willing to sign a written informed consent document.
- •2. Patient with severe chronic renal disease (according to the KDOQI/CTCAE eGFR or CrCl< 15 ml/min/1.73m2).
研究者
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