metastatic prostate carcinoma MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 64-rame (II) cloruro
Product Code: n.a
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: 64Cu(II)Cl2
Concentration unit: Bq/ml becquerel(s)/millilitre
Con
Sponsors
SPARKLE SRL
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. age>=50 years at the time of enrollment (There is no upper age limit that contraindicate the diagnostic test) 2. documented previous histological diagnosis of primitive prostate adenocarcinoma 3. subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgens antagonists) 4. previous clinical diagnosis of metastatic disease on bone, and/or lung, and/or lymphnode due to PCa (with involvement of pelvic region, and/or lumbar lymph node and/or sub phrenic), also documented with the restaging CT (See below) 5. recent disease progression (increase of PSA in serial determinations, and/or clinical progression and/or radiological), during ADT with clinical indication to restaging (also radiological) 6. availability of a Whole-body CT examination (with and without contrast medium), performed for restaging during the 20 days before the enrollment visit (slice thickness 80% 10. the absence of other significant co-morbidities (see: Exclusion criteria) 11. complete ability to understand the information reported in the trial informative leaflet for the subject 12. complete ability to sign the valid 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Anemia with Hb1.5 times the upper limit of the normal range 4. ALT >1.5 times the upper limit of the normal range 5. Total Bilirubin > 1.5 times the upper limit of the normal range 6. Clinical history and/or history of serological evidence for HBV infection 7. Clinical history and / or history of serological evidence for HCV infection 8. IRC more serious of stage II (GFR 1, or FE VS 28 23. Previous participation in clinical trials with exposure to ionizing radiation for medical purposes 24. Occupational exposure to ionizing radiation 25. Any condition, material, logistical, or subjective, which, even in the opinion of the Principal Investigator, may affect the compliance of the subject to the execution of procedure provided in the Protocol 26. Inability to understand the information reported in the trial informative leaflet for the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Initial assessment of the diagnostic sensibility, on a per-patient-basis, of whole body PET/CT, performed after the administration of 64Cu (II) Cl2, in the localization of metastatic lesions from PCa, of bones, lungs and lymph nodes (regional pelvic and/or lumbar and subfrenic nodes), preliminarly diagnosed on the basis of a Gold Standard surrogate, consisting of the integration of clinical and instrumental methods. ;Secondary Objective: • Initial assessment of the diagnostic sensibility, on a per- lesion basis, • Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in terms of target-to-background contrast • Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in term of intra-observer diagnostic reproducibility • Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in term of inter-observer diagnostic reproducibility • Assessment of optimization of post-injection times in which to perform 64Cu(II)Cl2 PET/CT, in term of per-patient and per-lesion diagnostic sensibility, target-to background contrast, intra-observer and inter-observer diagnostic reproducibility • Assessment of safety profile of the IMP in particular for the liver toxicity, deriving from the accumulation of the copper 64 in the liver • Assessment of the kinetic of IMP in the tumor tissue and in the near health tissue. ;Primary end point(s): A. The verification of matching between the positive diagnosis (uptake locations, defined as “positive”, according to the diagnostic criterion, ad hoc) by each observer (independently for each scan time post-injecting, and for each of both readings of the same scan, submitted at each observer twice, in anonymised and randomized mode), and the “lesion-index” previously identified (See: Chapter 11, “Procedure”) B. The assessment of the “target/background” (T/B) report is an endpoint for the purpose of the verification of the image quality; it is achieved by: a. Measurement of the value of SUVmax detected in th | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 8 months;Secondary end point(s): 1. Initial assessment of the diagnostic sensibility, on a per-patient basis, of 64Cu(II)Cl2 PET/CT, in the localization of metastatic lesions from PCa, of bones, lungs and lymph nodes (regional pelvic and/or lumbar and subfrenic nodes), preliminarly diagnosed, on the basis of a Gold Standard surrogate, consisting of an integration of clinical and instrumental methods 2. Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in terms of target-to-background contrast 3. Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in term of intra-observer diagnostic reproducibility 4. Assessment of the technical performance of 64Cu(II)Cl2 PET/CT in term of inter-observer diagnostic reproducibility 5. Assessment of optimization of post-injection times in which to perform 64Cu(II)Cl2 PET/CT, in term of per-patient and per-lesion diagnostic sensibility, target-to background contrast, intra-observer and inter-observer diagnostic reproducibility 6. Assessment of safety profile of the IMP, in particular for the liver toxicity, deriving from the accumulation of the copper 64 in the liver 7. Assessment of the kinetic of IMP in the tumor tissue and in the near health tissue. | — |
Countries
Italy
Contacts
Public Contactproject manager
sparkle s.r.l.
Outcome results
None listed