Prostate adenocarcinoma accounts for 11% of all malignancies, with a total 2.6 million new cases / year estimated in Europe. Mortality rate is 30.6 / 100,000 persons/year. Prostate cancer generally evolves relatively slow and as a result of local growth, the tumor may infiltrate the closest pelvic structures
Conditions
Interventions
Product Name: 11C-CHOLINE
Product Code: 11C-CHOL
Pharmaceutical Form: Injection
INN or Proposed INN: [11C]choline
Other descriptive name: choline C-11 injection
Concentration unit: MBq megabecquerel(s
Sponsors
IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients included must meet the inclusion criteria as follow: we will enroll adult patients (aged>18years) with prostate cancer and suspected skeletal metastasis referring us at the “Nuclear Medicine Unit, IRCCS AOU San Martino - IST for specialist evaluation and that have signed the informed consent for study participation. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: The present study will not include healthy volunteers. Likewise, patients affected by conditions requiring emergency treatment, underage, mentally incapable or those who refuse to sign the informed consent will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study we aim to evaluate sensitivity and specificity of [11C]-choline PET / CT in identifying the bone involvement in prostate cancer patients and to compare it with that of conventional imaging most largely used for this purpose (bone scan with technetium-99m oxidronate and/or CT scan). ;Secondary Objective: Not applicable;Primary end point(s): For each patient, the study provides three distinct moments (hereinafter time 1, time 2, time 3). At Time 1 patients matching inclusion criteria are enrolled, sign informed consent, and consequently undergo PET / CT with [11C]-choline and convention imaging procedure (the time elapsed between the two examinations must not be greater than 30 days). At time 2 results of PET / CT with [11C]-choline and conventional imaging are evaluated. The time 3 provides, for each patient, the comparison of the results obtained by the two methods performed. In this study, each patient is the control of himself.;Timepoint(s) of evaluation of this end point: The time elapsed between the two examinations must not be greater than 30 days. The comparison between the methods will be after the second examination. Duration of the study 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Italy
Contacts
Public ContactSEGRETERIA DEL COMITATO ETICO
IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro
Outcome results
None listed