18F-fluciclovine PET/CT and 18F-DCFPyL PET/CT in patients with biochemical recurrence of disease after radical prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial - RENARD trial

Amsterdam UMC, VU University Medical Center0 个研究点目标入组 50 人开始时间: 2021年4月22日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Age = 18 years.
•Histopathological confirmed prostate adenocarcinoma per original diagnosis.
•History of RARP.
•Biochemical recurrence of prostate cancer based on two consecutive measurable PSA levels of 0.2 -2.0 ng/mL.
•Ability to understand and sign the written informed consent form.
•Patients who can undergo all study procedures per investigator’s 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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Another active malignant tumor, except skin basal cell carcinoma.
•pN1 disease after ePLND.
•Any change in prostate cancer treatment between both PET/CT scans.
•History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection).
•History of salvage radiotherapy of the prostate bed.
•History of cryotherapy, high-intensity focused ultrasound (HIFU).
•Treatment with androgen deprivation therapy (ADT) in the past 30 days or ongoing.
•Unable to lie supine or still for imaging.
•Known allergy to investigational or reference products or to any excipients.
•Unable to provide written consent (linguistic or psychological inability).
•Uncooperative, in the Investigator’s opinion.

发起方

Amsterdam UMC, VU University Medical Center