se of 64CuCl2 PET/CT Imaging in the selection of patients with prostate cancer in biochemical relapse after prostatectomy, to be successfully treated with salvage radiotherapy on the prostatic bed - 64CuCl2 PET/CT for cancer on the prostatic bed

SPARKLE SR0 个研究点目标入组 138 人开始时间: 2018年10月4日最近更新: 2018年10月15日

适应症

试验速览

暂无简介。

•1.>=45 years old at the moment of enrolment in the study
•2.Previous documented histological diagnosis of primitive prostate adenocarcinoma
•3.Prior radical prostatectomy surgery
•4.Zeroing of the circulating PSA values
•5.Presence of biochemical relapse documented by circulating PSA values raising in two consecutive determinations performed within three weeks of distance (values over 0.2ng / ml and lower than 1.1 ng /ml)
•6.Absence of distant metastatic lesions not shown by previous mpMRI and PET / CT-18F-choline tests
•7.Negative clinical history for other pre-existing or current neoplastic diseases, with the exception of non-melanoma skin cancers
•8.Previous execution of 18F-FCH-PET not older than 30 days
•9.Patients to be treated with rescue radiotherapy on the prostatic bed
•10.Previous execution of mpMRI not older than 30 days
•11.Karnofski’s Index = 80%
•12.Absence of other relevant co-morbidities (see: exclusion criteria)
•13.Full ability to understand the information in the informed consent sheet
•14.Full ability to sign informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 58
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Anemia with Hb <9 gr / dl
•2. Subject treated with ADT (orchiectomy, and / or LHRH agonists, and / or androgen antagonists)
•3. Presence of symptoms or signs of sepsis and / or evidence of acute infections
•4. AST> 1.5 times the upper limit of the normal range
•5. ALT> 1.5 times the upper limit of the normal range
•6. Total bilirubin> 1.5 times the upper limit of the normal range
•7. Clinical history and / or previous serological evidence for HBV infection
•8. Clinical history and / or previous serological evidence for HCV infection
•9. copper metabolism diseases (Menkes’ disease, Wilson’s disease)
•10. Subjects who have received chemotherapy in the previous 120 days
•11. Radiotherapy performed in the previous 120 days
•12. Major surgery performed in the previous 120 days
•13. Presence of lesions in the prostatic bed evidenced by previous mpMRI and / or US examinations
•14. Previous participation in clinical trials with exposure to ionizing radiation for therapeutic purposes
•15. Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the subject's compliance with the execution of the procedures established by the Protocol
•16. Inability to understand the contents of the information documentation for the subject

发起方

SPARKLE SR