Comparative study of 68Ga-PSMA-11 PET and 18F-Fluorocholine PET in the detection of Recurrence in Prostate Cancer Patients after Radical Treatment - 68Ga-PSMA-11 PET and 18F-Fluorocholine PET in Recurrent Prostate Cancer

ICNAS Produção Lda.0 个研究点目标入组 46 人开始时间: 2017年8月10日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•Patients that gave free written consent to participate in the study trough the Inform Consent Form;
•¿ Patients willing to comply with all study procedures and show availability for the duration of the study;
•¿ Men with age between 18 and 80 years old at time of enrolment;
•¿ Patients diagnosed with prostate cancer that have followed a radical treatment by prostatectomy or radiotherapy;
•o Biochemical relapse:
•After surgery: the last two PSA measurements had values >0.2ng/ml.
•After radiotherapy: PSA increase of 2.0ng/ml above the nadir.
•o Residual disease:
•After surgery: positive PSA level after surgery
•After radiotherapy: two consecutive PSA measurements PSA>0.2 ng/ml (attention to false positives).
•¿ Patients that have a prescription to perform a 18F-Fluorocholine PET/CT scan;
•¿ Patients with PSA level <10 ng/ml at study inclusion;
•¿ Patients with a life expectancy superior to 12 months;
•¿ Patients considered for local salvage treatment
•¿ Patients with an ECOG performance status ¿ 2;
•¿ Patient under the National Healthcare System;
•¿ Patients physically and psychologically able to participate in the study.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•Patients presenting a known hypersensitivity to the active substance or any excipient of the investigational drug;
•¿ Patients with known malignant disease, irrespectively of how long it has been diagnosed (with the exception of basal-cell carcinomas);
•¿ Patients with alcohol or drug addiction, who have a serious illness, mental disorder or any other cause that could affect their participation in the study;
•¿ Patients exposed to any investigational drug or device in the six months prior to the date of enrolment.

发起方

ICNAS Produção Lda.