Not yet taking people in ItalyPhase 3
Compares a copper scan with a choline scan for prostate cancer spread
Tests a copper-based PET scan against a choline PET scan to find prostate cancer spread.
Key facts
- Who runs it
- A.C.O.M. Advanced Center Oncology Macerata S.r.l.
- Where
- Genoa and Rome, ItalySee the 2 sites
- Registry title
- 64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 285 people, planned
- Started
- 23 Jun 2019
- Planned end
- 31 May 2025
- Type of study
- Interventional
- Record updated
- 9 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 45 or older with proven prostate cancer who need staging or restaging scans because of a risk of spread.
- Age
- 45 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma confirmed by tissue test, needing staging or restaging, with risk of metastasis (before primary treatment, after primary treatment with rising PSA, or rising PSA during treatment).
- Earlier treatment
- Cannot have taken part before in a trial using ionizing radiation for treatment.
- Biomarker or test result
- PSA criteria by group: before primary treatment PSA above 20, or Gleason score above 7, or cT2c; after primary treatment PSA 0,2 ng/ml in two measurements in a row, or a 2 ng/ml rise over the lowest PSA value; during treatment, three rises in PSA at least one week apart, with PSA above 2ng/ml. Karnofsky index of 80% or more.
Main reasons for not taking part
- Anemia with Hb below 9 gr/dL
- Signs of sepsis or acute infection
- AST, ALT or total bilirubin more than 1.5 times above the normal range
- Copper metabolism disease (Menkes disease, Wilson disease)
- Other past or current cancer, except non-melanoma skin cancer
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Ente Ospedaliero Ospedali Galliera Di GenovaGenoa, ItalyNot yet recruiting
- IFO-Regina Elena Institute for Cancer ResearchRome, ItalyNot yet recruiting
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.
- Plain-language title
- Compares a copper scan with a choline scan for prostate cancer spreadGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 9 September 2026