? Patients with prostate cancer treated with radical prostatectomy or radiotherapy presenting with suspect progression(rising PSA) of local or distant (lymphnodes or bones) already scheduled for a 11C-Choline PET/CT (performed at enrolment and during the follow-up) MedDRA version: 14.1 Level: HLT Classification code 10036908 Term: Prostatic neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ANTI-3-18F-FACBC
Product Code: ANTI-3-18F-FACBC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: l’anti-1-amino-3-fluorine 18-fluorocyclobutane-1-carboxylic acid
Current
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • prostate cancer treated with radical prostatectomy or radiotherapy at least 3 months before. • recurrent prostate carcinoma suspected on the basis of previous American Society for Radiology and Oncology (ASTRO) criteria of three consecutive increases in PSA level, the ASTRO-Phoenix criteria of an increase in PSA level of at least 2.0 ng/mL above the nadir level after radiation therapy, and/or an absolute PSA level of 0.3 mg/mL or greater after prostatectomy • patients who have already performed conventional imaging tests (MR, CT, 11C-Choline PET/CT) • age = 18 years • signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • radical prostatectomy or radiation therapy performed within 3 months • age <18 • patients of un sound mind
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?Evaluate: Anti-3-18F-FACBC PET/CT sensitivity in comparison to 11C-Choline PET/CT for the detection of disease relapse;Secondary Objective: ?Evaluate: the predictive value Anti-3-18F-FACBC PET/CT in comparison to disease evolution. ?Evaluate: the specificity and accuracy of Anti-3-18F-FACBC PET/CT. Compare the Anti-3-18F-FACBC PET/CT results and biochemical parameters, imaging procedures and clinical visits at enrolment and during the follow-up;Primary end point(s): ?Compare in terms of positivity/negativity the results of Anti-3-18F-FACBC PET/CT and 11C-Choline PET/CT at enrolment and during the follow-up;Timepoint(s) of evaluation of this end point: at time one (1 single administration IMP-1) and after 12 months of follow-up (time two) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Compare the results of Anti-3-18F-FACBC PET/CT in terms of positivity/negativity and progression free survival. ? Specificity and accuracy of Anti-3-18F-FACBC PET/CT having as gold standard the routine tests performed at enrolment and during the follow-up;Timepoint(s) of evaluation of this end point: at time one (1 single administration IMP-1) and after 12 months of follow-up (time two) | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina nucleare-C.Nanni
AOU di Bologna, Policlico S.Orsola-Malpighi
Outcome results
None listed