Copper (64Cu) chloride for Prostate cancer | Biochemical recurrence of prostate cancer after radical prostatectomy

Inclusion criteria

• {"criterion_text":"- Age>=45 years at the time of enrollment.\n- Previous documented histological diagnosis of primitive prostate adenocarcinoma.\n- Previous prior radical prostatectomy surgery.\n- Zeroing of circulating PSA values.\n- Presence of biochemical relapse documented by an increase in circulating PSA values in two consecutive determinations (values between 0.2 ng/ml and 1 ng/ml)\n- Absence of distant metastatic lesions not detectable by previous mpMRI and PET/CT imaging tests (18F-choline and/or PSMA).\n- Negative clinical history for other previous or current neoplastic diseases, with the exception of non-melanoma skin carcinomas.\n- Previous execution 18F-FCH PET and/or PSMA PET not older than 30 days.\n- Patients to be treated with salvage radiotherapy to the prostate bed.\n- Previous execution mpMRI and/or US performance not older than 30 days.\n- Karnofski Index >= 80%\n- Absence of other relevant comorbidities (see: exclusion criteria).\n- Full ability to understand the information reported in the informed consent sheet.\n- Full ability to sign informed consent."}

Exclusion criteria

• {"criterion_text":"- Anemia with Hb <9 gr/dl\n- Subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgen antagonists).\n- Presence of symptoms or signs of sepsis and/or evidence of acute infections.\n- AST>1.5 times the upper limit of the normal range.\n- ALT>1.5 times the upper limit of the normal range.\n- Total bilirubin>1.5 times the upper limit of the normal range.\n- Copper metabolism diseases (Menkes’ disease, Wilson’s disease).\n- Subjects who have received chemotherapy in the previous 120 days.\n- Radiotherapy performed in the previous 120 days.\n- Major surgery performed in the previous 120 days.\n- Presence of lesions in the prostatic bed evidenced by previous mpMRI and/or US examinations.\n- Previous participation in clinical trials with exposure to ionizing radiation for therapeutic purposes.\n- 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.\n- Inability to understand the contents of the information documentation for the subject."}

Primary endpoints

• {"endpoint_text":"- 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-).","definition_or_measurement_approach":"PSA change calculated as difference between PSA measured before treatment and minimum PSA measured during observational period; 64CuCl2-PET positivity (B+) defined as detectable focal uptake in the prostate bed greater than background; otherwise negative (B-)."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Maximum PSA variation in subgroups (PSA<0.5; PSA 0.5–1) analysed using ROC curve to evaluate detection ability."}
• {"endpoint_text":"- 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-;","definition_or_measurement_approach":"Tabulation and evaluation of clinical impact (treatment modification) of positive 64CuCl2-PET findings outside prostate bed, considering R+/R- classification."}
• {"endpoint_text":"- Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated.","definition_or_measurement_approach":"Diagnostic performance metrics (sensitivity, specificity, PPV, NPV, AUC) to be calculated."}
• {"endpoint_text":"- The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves.","definition_or_measurement_approach":"Median time to PSA nadir estimated using Kaplan–Meier survival analysis."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Correlation of SUV values of index lesions with salvage radiotherapy (SRT) response to identify SUV cut-offs of significance."}
• {"endpoint_text":"- Adverse events will be recorded and classified according to the EMA guidelines.","definition_or_measurement_approach":"Safety assessed by recording and classifying adverse events per EMA guidelines."}

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

4

Number Of Participants

138

Primary sponsor

Full Name

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

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy