Prostate cancer at risk of developing metastatic lesions MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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: Rame cloruro (64CuCl2)
Current Sponsor code: (64Cu)CuCl2
Concentration unit:
Sponsors
A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age >=45 years at the enrollment time 2. Documented hystologically diagnosis of PCa 3. Clinical indication to staging or restaging 4. Imaging of MRI and/or TAC and/or bone scintigraphy and/or PET and/or other imaging techniques 5. Patient at risk of developing metastasis during their illness according symptoms presence or EAU criteria of risk as follows: • At diagnosis : PSA > 20 or GS > 7 or cT2c; or any PSA –any Gs cT3-4 or cN+; • At restaging after primary treatment: PSA 0.2 ng/ml or PSA increase of 2ng/ml; • After-staging for biochemical progression during treatment: 3 PSA assay demonstrating an increase > 50% respect to nadir and a PSA > 2 ng/ml. 6. No other concomitant or previous malignant tumors, except for non-melanoma skin cancers 7. Karnofski index = 80% 8. No other relevant disease (cfr exclusion criteria) 9. Ability to understand the contents of the information material for the subject 10. Ability to sign the 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 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Anemia (Hb1.5 higher than normal range 4. ALT >1.5 higher than normal range 5. Total bilirubin > 1.5 higher than normal range 6. Copper metabolism disease (m.di Menkes, m.di Wilson) 7. Previous participation in trials with exposure to ionizing radiation for therapeutic purposes 8. 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 9. Inability to understand the contents of the information documentation for the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study design is based on a co-primary endpoint for the evaluation of diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT compared to 18F-choline PET/CT. The assessment of sensitivity and specificity for the co-primary endpoint is expressed on a patient basis, in relation to the whole individual.;Secondary Objective: 1. to evaluate the higher diagnostic accuracy of 64CuCl2 PET/CT in the identification of metastases compared to 18F-choline PET/CT (diagnostic performance); 2. estimate the sensitivity and specificity between the two PET/CT scans (64CuCl2 and 18F choline) on a regional basis (chest, abdomen, pelvis) and on a lesion basis (bone, lymph nodes and visceral) (diagnostic performance); 3. Correlate the sensitivity of 64CuCl2 PET/CT and 18F choline PET/CT to different PSA levels (diagnostic performance);;Primary end point(s): To evaluate the diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT compared to 18F-choline PET/CT on a patient basis, in relation to the whole individual. In particular, 18F-choline PET/CT and 64CuCl2 PET/CT will be evaluated as positive (PET+) in case of evidence of pathological focal uptake at site(s) compatible with metastases (bone, lymph node and visceral; they will otherwise be judged negative (PET-) when no pathological focal uptake is detectable.;Timepoint(s) of evaluation of this end point: at the end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The diagnostic accuracy of the two PET/CT scans (64Cu and 18F-choline) will be assessed by area under the ROC curve (AUC) and the difference of the curve between the two methods will be assessed, 2. Lesion-based and region-based sensitivity and specificity will be analyzed by aggregation according to body region (thorax, abdomen, pelvis) and anatomical-pathological character of lesions (bone, lymph nodes, visceral) 3. 64Cu PET and 18F-choline sensitivity will be correlated with PSA levels and calculated as per the primary objective, 4. Patients will be classified into non-metastatic, oligometastatic and multimetastatic with both PET/CT. (oligometastatic will be defined as a patient with a maximum number of three metastases), 5. In each patient, the different impact determined by the two PETs on decision thinking (impact of the test compared to the pre-test probability) will be evaluated with calculation of positive and negative predictive values, 6. In each patient, the impact determined by the 64Cu PET/CT on the clinical outcome will be evaluated by means of the patient's follow-up data and in particular the consequences of a misdiagnosis (delay of treatment or unnecessary interventions) will be evaluated, 7. The inter-observer reproducibility of 64CuCl2 and 18F-FCH PET/CT will be evaluated.;Timepoint(s) of evaluation of this end point: at the end of trial | — |
Countries
Italy
Contacts
Public ContactUfficio amministrativo
A.C.O.M. S.R.L.
Outcome results
None listed