Copper (64Cu) chloride for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Age >=45 years at the enrolment time."}
• {"criterion_text":"- Full capacity to sign informed consent."}
• {"criterion_text":"- Previous documented histological diagnosis of primary prostate adenocarcinoma."}
• {"criterion_text":"- Clinical indication on staging or restaging."}
• {"criterion_text":"- Imaging examination MRI and/or TAC and/or Bone Scan and/or PET and/or other imaging techniques."}
• {"criterion_text":"- Patient at risk of developing metastasis during their illness according to symptoms presence or EAU criteria of risk as follows:Class A: high-risk patients before primary treatment: PSA> 20 or GS> 7 or cT2c; or any PSA also Gs cT3-4 or cN +, histological confirmation in the prostate and lymph nodes (if possible), for patients who have not already started radiotherapy. Class B: re-staging after the primary treatment: PSA value 0,2 ng/ml in two different consecutive measurements or 2 ng/ml increase in serum PSA over the PSA nadir value. Class C: post-staging for biochemical progression during treatment; (CRPC); three consecutive increases in PSA at least one week apart, resulting in two 50% increases above nadir and a PSA>2ng/ml."}
• {"criterion_text":"- Negative medical history of other previous or ongoing neoplastic diseases, with the exception of non-melanoma skin carcinomas."}
• {"criterion_text":"- Karnofski index ≥ 80%."}
• {"criterion_text":"- No other relevant comorbidities (see exclusion criteria)."}
• {"criterion_text":"- Full comprehension of the information contained in the illustrative documentation for the Subject."}

Exclusion criteria

• {"criterion_text":"- Anemia with Hb value<9 gr/dL."}
• {"criterion_text":"- Symptoms or signs of sepsis and/or evidence of acute infections."}
• {"criterion_text":"- AST value>1.5 higher than normal range."}
• {"criterion_text":"- ALT value>1.5 higher than normal range."}
• {"criterion_text":"- Total Bilirubin value>1.5 higher than normal range."}
• {"criterion_text":"- Copper metabolism disease (Menkes disease, Wilson disease)."}
• {"criterion_text":"- Previous participation to clinical trials with ionizing radiation for therapeutic scope."}
• {"criterion_text":"- Any condition, material, logistics, or Subjective, which, even in the Principal Investigator’s opinion, may condition the subject's compliance with the execution of the procedures established by the Protocol."}
• {"criterion_text":"- Inability to understand the content of the information documents for the Subject."}

Primary endpoints

• {"endpoint_text":"- To evaluate the diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT versus 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 in correspondence with site(s) compatible with metastases (bone, lymph node and visceral;otherwise they will be judged negative (PET-) when no pathological focal uptakes are detectable","definition_or_measurement_approach":"Evaluation expressed on a patient basis; scans evaluated as PET+ if evidence of pathological focal uptake at sites compatible with metastases (bone, lymph node, visceral); sensitivity and specificity will be calculated comparing 64Cu PET/CT versus 18F-choline PET/CT on the whole individual."}

Secondary endpoints

• {"endpoint_text":"- The diagnostic accuracy of the two PET/CT (64Cu and 18F-choline) will be assessed by area under the ROC curve (AUC) and the difference in the curve between the two methods will be evaluated.","definition_or_measurement_approach":"Diagnostic accuracy assessed by AUC of ROC curves; difference between methods' ROC curves will be evaluated."}
• {"endpoint_text":"- Sensitivity and specificity on a lesion-based and region-based basis will be analysed by aggregation according to body region (chest, abdomen, pelvis) and anatomo-pathological character of the lesions (bone, lymph node, visceral).","definition_or_measurement_approach":"Sensitivity and specificity calculated on lesion-based and region-based aggregation (chest, abdomen, pelvis) and by lesion type (bone, lymph node, visceral)."}
• {"endpoint_text":"- The sensitivity 64Cu PET and 18F-choline will be correlated with PSA levels and calculated as for the primary objective.","definition_or_measurement_approach":"Correlation analysis of sensitivity of each PET modality with PSA levels; sensitivity calculated as for primary endpoint."}
• {"endpoint_text":"- Patients will be classified into non-metastatic, oligometastatic and multimetastatic with both PET/CT. (A patient with up to three metastases will be defined as oligometastatic).","definition_or_measurement_approach":"Classification of patients by metastasis burden (non-metastatic, oligometastatic [≤3 metastases], multimetastatic) based on each PET/CT."}
• {"endpoint_text":"- In each patient the different impact of the two PET scans on decision-making (impact of the test versus pre-test probability) will be assessed with calculation of positive and negative predictive values.","definition_or_measurement_approach":"Assessment of impact on decision-making via calculation of positive and negative predictive values relative to pre-test probability for each scan."}
• {"endpoint_text":"- In each patient the impact determined by the 64Cu PET/CT on clinical outcome will be evaluated by means of the patient's follow-up data and in particular the consequences of misdiagnosis (delay of treatment or unnecessary intervention) will be assessed.","definition_or_measurement_approach":"Impact on clinical outcome assessed using patient follow-up data, specifically consequences of misdiagnosis (treatment delays or unnecessary interventions)."}
• {"endpoint_text":"- The inter-observer reproducibility of 64CuCl2 and 18F-FCH PET/CT will be evaluated.","definition_or_measurement_approach":"Inter-observer reproducibility will be evaluated for both imaging modalities (method not further specified in provided data)."}

Italy

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

10-09-2025

Processing Time Days

226

Number Of Sites

2

Number Of Participants

285

Primary sponsor

Full Name

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy