better diagnostic accuracy and ability to detect multiple metastases of the PET exam with a new experimental radiopharmaceutical (64CuCl2) in the diagnosis of metastases in patients with prostate cancer compared to the PET / CT examination performed with 18F-choline.
- Conditions
- prostate cancer at risk of developing metastatic lesionsMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-000744-10-IT
- Lead Sponsor
- SPARKLE SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 111
1.Age >=45 years at the enrollment time
2.Documented hystologically diagnosis of PCa
3.Clinical indication to staging or restaging
4.Imaging of MRI and/or TAC and/or bone scintigraphy not older than 30 days
5.Previous execution of 18F-FCH not older than 30 days
6.Patient at risk of developing metastasis during their illness according symptoms presence or EAU criteria of risk as follows:
•At diagnosis : PSA > 20 or GS > 7 or cT2c; or any PSA –any Gs cT3-4 or cN+;
•At restaging after primary treatment: PSA > 1 ng/ml;
•After-staging for biochemical progression during treatment: 3 PSA assay demonstrating an increase > 50% respect to nadir and a PSA > 2 ng/ml.
7.No other concomitant or previous malignant tumors, except for non-melanoma skin cancers
8.Karnofski index ¿ 80%
9.No other relevant disease (cfr exclusion criteria)
10.Ability to understand the contents of the information material for the subject
11.Ability to sign the Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 111
1.Anemia (Hb<9 gr/dl)
2.Symptoms or signs of sepsis and / or evidence of acute infections
3.AST >1.5 higher than normal range
4.ALT >1.5 higher than normal range
5.Total bilirubin > 1.5 higher than normal range
6.Copper metabolism disease (m.di Menkes, m.di Wilson)
7.Previous participation in trials with exposure to ionizing radiation for therapeutic purposes
8.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
9.Inability to understand the contents of the information documentation for the subject
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method