cancer on the prostatic bed MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 64-Rame Cloruro
Product Code: [64Cu(II)Cl2]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLORURO DI RAME (Cu-64)
Current Sponsor code: (64Cu)CuCl2
Other descriptive n
Sponsors
A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
Eligibility
Sex/Gender
Male
Inclusion criteria
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: 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
Exclusion criteria: 1. Anemia with Hb 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the diagnostic accuracy of PET with 64CuCl2 in the diagnosis of local recurrence (PSA> 0.2, <= 1ng / ml) of prostatic carcinoma after radical prostatectomy, in patients negative to traditional methods.;Secondary Objective: 1. to evaluate the ability to detect relapse sites in subgroups with PSA <0.5 and between 0.5 and 1; 2. to evaluate the clinical impact (treatment modification) of cases with positive 64CuCl2-PET in lymph nodes or for distant metastases (M+); 3. to evaluate all the performance indicators of interest of the 64CuCl2-PET referring to the response after Salvage Radiotherapy 4. to estimate the median time to reach the minimum value (NADIR) of the PSA in B+ patients; 5. to evaluate the optimal SUV for the detection of index lesions in the prostate bed; 6. to evaluate the safety aspects and the surveillance of adverse events. ;Primary end point(s): To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-) The SRT response is defined as positive (R +) if a PSA decrease of =15% respect to the initial PSA value otherwise the SRT response is defined as negative (R -). It will be considered true positive patients (B+)(R+) and true negatives (B-)(R-).;Timepoint(s) of evaluation of this end point: 5 weeks, 10 weeks and 4 months since the beginning of radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Calculation of the maximum variation of PSA in the subgroups of patients with PSA <0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence 2) In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R + / R-; 3) Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated. 4) The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves. 5) The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant 6) Adverse events will be recorded and classified according to the EMA guidelines. ;Timepoint(s) of evaluation of this end point: at trial completion | — |
Countries
Italy
Contacts
Public ContactProject Manager
Sparkle srl
Outcome results
None listed