Interventional two arms open-label study for evaluating the diagnostic performance of PET PSMA in patients affected by biochemical recurrent prostate cancer. - PSMA-2018

OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO0 个研究点目标入组 894 人开始时间: 2021年1月5日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•1.Histological confirmation of prostate malignancy.
•2.Patient must have had their primary tumor treated with surgery and/or radiation and salvage radiation to the prostate bed or pelvis is allowed.
•3.Patient must be = 18 years of age, have the ability to understand, and the willingness to sign, a written informed consent document.
•4.Patient must have an Eastern Cooperative Oncology Group performance status = 2.
•5.Diagnosis of biochemical failure:
•For patients treated with surgery: arise of PSA = 0.2 ng/ml.
•For patients treated with radical RT: PSA level +2 ng/ml from nadir.
•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 358
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 536

•1.More than 3 years of ADT, with the most recent ADT treatment having occurred < 6 months prior to enrollment.
•2.Spinal cord compression or impending spinal cord compression.
•3.Receipt of any other investigational agents in the previous 3 months
•4.Inability to lie flat during or tolerate PET/CT.
•5.Refusal to sign informed consent
•6.Participation in a concurrent clinical trial.

发起方

OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO