A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO

CYCLOPHARMA0 个研究点目标入组 217 人开始时间: 2020年2月20日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•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

•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. Unable to lie supine for imaging
•8. Known allergy to investigational or reference products or to any excipients
•9. Unable to provide written consent (linguistic or psychological inability)
•10. Participation in another clinical study within one month prior to inclusion
•11. Uncooperative, in the Investigator's opinion.
•12. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship

发起方

CYCLOPHARMA