64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer
Key facts
- Where
- Genoa és Rome, OlaszországSee the 2 sites
- Phase
- 3. fázis
Where in Olaszország
- Ente Ospedaliero Ospedali Galliera Di GenovaGenoa, OlaszországToborzás még nem indult
- IFO-Regina Elena Institute for Cancer ResearchRome, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- A.C.O.M. Advanced Center Oncology Macerata S.r.l.
- Trial code
- EU 2025-520861-29-00
- Record updated
- 2026. szeptember 9.
- Original description
The study design is based on a co-primary endpoint for the evaluation of the diagnostic performance in terms of sensitivity and specificity of 64CuCl2 PET/CT compared to 18Fcholine PET/CT. The evaluation of sensitivity and specificity for the co-primary endpoint is expressed on a patient basis, in relation to the entire individual.Read full original descriptionShow less
Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.
The study design is based on a co-primary endpoint for the evaluation of the diagnostic performance in terms of sensitivity and specificity of 64CuCl2 PET/CT compared to 18Fcholine PET/CT. The evaluation of sensitivity and specificity for the co-primary endpoint is expressed on a patient basis, in relation to the entire individual.
Inclusion: Age >=45 years at the enrolment time; Full capacity to sign informed consent; Previous documented histological diagnosis of primary prostate adenocarcinoma; Clinical indication on staging or restaging; Imaging examination MRI and/or TAC and/or Bone Scan and/or PET and/or other imaging techniques; 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; Negative medical history of other previous or ongoing neoplastic diseases, with the exception of non-melanoma skin carcinomas; Karnofski index ≥ 80%; No other relevant comorbidities (see exclusion criteria); Full comprehension of the information contained in the illustrative documentation for the Subject.
Exclusion: Previous participation to clinical trials with ionizing radiation for therapeutic scope; Symptoms or signs of sepsis and/or evidence of acute infections; Copper metabolism disease (Menkes disease, Wilson disease); 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; AST value>1.5 higher than normal range; ALT value>1.5 higher than normal range; Total Bilirubin value>1.5 higher than normal range; Anemia with Hb value<9 gr/dL; Inability to understand the content of the information documents for the Subject.