se of the diagnostic PET with 64CuCl2 in order to select patients, in which a disease relapse is shown after prostate surgical removal, to be successfully treated to radiation therapy on the prostate bed

Phase 1

Conditions: cancer on the prostatic bed
MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-004332-11-IT

Lead Sponsor: SPARKLE SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 138

Inclusion Criteria

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

Exclusion Criteria

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