EUCTR2020-000121-37-NL进行中（未招募）1 期
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 217
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
- •2. Age superior or equal to 18 years.
- •3. Histopathological proven prostate adenocarcinoma per original diagnosis.
- •4. First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA = 0.2 ng/mL confirmed by a subsequent PSA value of =0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir.
- •5. Able and willing to provide informed consent and comply with protocol requirements
- •6. Patient who can undergo all study procedures per Investigator’s point of view
- •7. Patient with social insurance cover.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
排除标准
- •1. ECOG > 2
- •2. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection)
- •3. History of adjuvant radiotherapy
- •4. History of cryotherapy, high-intensity focused ultrasound (HIFU)
- •5. Other active malignant tumour
- •6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing
- •7. Treatment with colchicine in the past 8 days or ongoing
- •8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing
- •9. Unable to lie supine for imaging
- •10. Known allergy to investigational or reference products or to any excipients
- •11. Unable to provide written consent (linguistic or psychological inability)
- •12. Participation in another clinical study within one month prior to inclusion
- •13. Uncooperative, in the Investigator's opinion.
- •14. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
研究者
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