2025-520861-29-00Not yet recruitingPhase 3
64CuCl2 PET/CT VS 18F-choline PET/CT in prostate cancer
Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 285 (estimated)
- First submitted
- 27 Jan 2025
- Start date
- 23 Jun 2019
- Lead sponsor
- A.C.O.M. Advanced Center Oncology Macerata S.r.l.
- Diseases
- Prostate cancer
- EU CT number
- 2025-520861-29-00
- EudraCT number
- 2019-000744-10
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 285
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation to clinical trials with ionizing radiation for therapeutic scope.
Other illness
- 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.
Lab values
- 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.
Other
- Anemia with Hb value<9 gr/dL.
- Inability to understand the content of the information documents for the Subject.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ente Ospedaliero Ospedali Galliera Di Genova | Genoa | Italy | Not yet recruiting |
| IFO-Regina Elena Institute for Cancer Research | Rome | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.