68Ga-PSMA-PET/CT for detection of recurrent prostate cancer - 68Ga-PSMA-PET/CT

AZIENDA USL DELLA VALLE D'AOSTA0 个研究点目标入组 62 人开始时间: 2021年6月8日最近更新: 2021年8月24日

试验速览

暂无简介。

•2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigationale nature of study
•3.ECOG 0-1
•4.Hystologically confirmed prostate cancer
•5.Previous prostatectomy and/or radiotherapy
•6.Biochemical recurrence confirmed by elevated PSA value following initial therapy (recent blood test results up to 4 weeks):
•-For patients status post prostatectomy, a PSA >/= 0.2 ng/ml and < 4 ng/ml
•-For patient status post radiation therapy for prostate cancer, any PSA increase from radiation therapy nadir but < 4 ng/ml
•7.Recent blood test results (up to 4 weeks) as follows: WBC=3000/mm3 , Absolute neutrophil count ANC=1500/mm3, PLT=100000/mm3 , Hb=10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine <1.5 x ULN
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1.Inability to stay lay for the entire imaging time (e.g. cough, severe arthritis, etc)
•2.Inability to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)
•3.Patients with known CRPC status, as defined by EAU Guidelines and urologists or medical oncologists evaluation
•4.Prior or concomitant chemotherapy
•5.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug
•6.Patients exceeding the weight limitations of the scanner ore are not able to enter the bore of the PET scanner due to BMI
•7.Other concomitant or previous malignancies, with the exception of basal cell skin tumors/superficial bladder cancer and any cancer that has been in complete remission for > 5 years.
•8.Recovery from major trauma including surgery within 4 weeks prior to PET imaging
•9.Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study

发起方

AZIENDA USL DELLA VALLE D'AOSTA