Genitourinary tract tumors in male patients
Conditions
Interventions
Trade Name: Cupymina
Product Name: Cuprymina
Pharmaceutical Form: Injection
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Over 18 y/o patients at enrolling; 2. Patient afflicted with kidney, bladder or penis neoplasm elegible for demolitive surgery; 3. Histologically documented prostate cancer afflicted patients, in treatment with ADT (orchiectomy and/or LHRH agonists and/or androgen antagonists); patients with diagnosis of metastatic prostate cancer, detectable at re-staging TC scan too; recent disease progression (serial PSA increasing and/or clinical or radiological progression), under ADT, with clinical indication to restaging, even radiological. 4. Availability of a re-staging whole body CT scan (with and without contrast media) executed in 20 days prior to the enrollement (slice thickness 80% 8. Absence of relevant comorbidities 9. Plain fitness to plead all the informations given in the Subject Illustration Documentation. 10. Plain fitness to subscribe an effective informd consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Anemia (Hb1 or LVEF 28 23. Previous partecipation to clinical trials involving exposure to ionizing radiations with therapeutical purposes. 24. Work related exposure to ionising radiations 25. Any material, logistical or subjective condition that, even in the opinion of the principle experimenter, could condition subject’s compliance to execution of any of the procedures expected by the protocol 26. Subject’s inhability to understand informative documentation content. 27. Pregnancy -? Mandatory negative pregnancy test for women in fertile age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 15 days;Secondary Objective: 1) lesion-based sensitivity of whole body PET/TC scan after CuCl2 somministration in primary and metastatic lesions. 2) Techincal performance evaluation of CuCl2 PET/TC scan [target/background (T/B) contrast] ;Primary end point(s): Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events).;Main Objective: Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 days;Secondary end point(s): 1) lesion-based sensitivity of whole body PET/TC scan after CuCl2 somministration in primary and metastatic lesions. 2) Techincal performance evaluation of CuCl2 PET/TC scan [target/background (T/B) contrast] | — |
Countries
Italy
Outcome results
None listed