Patients affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection MedDRA version: 17.0 Level: LLT Classification code 10036946 Term: Prostatic cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: fluciclovine
Product Code: 18F-FACBC
Pharmaceutical Form: Solution for injection
Sponsors
AOU di Bologna Policlinico S.Orsola-Malpighi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects with biopsy-proven adenocarcinoma of the prostate 2. Moderate- to high risk prostate cancer as defined by: -Moderate risk: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL; -High risk: T3a or Gleason score 8-10 or PSA > 20 ng/mL. 3. Staging according to conventional preoperative workup tests (digital rectal examination, transrectal ultrasound, biopsy, likelihood of lymph node metastasis with clinical nomograms, Choline PET/CT) 4. Choline PET/CT negative for bone metastases 5. Surgical plan: prostatectomy with limited or extended lymph node dissection within 40 days from the imaging 6. Age=18 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Inability to undergo 18F-FACBC PET/CT scanning for any reason. 2. Prior invasive malignancy (except basal cell carcinoma) unless disease-free for a minimum of 3 years 3. Severe acute co-morbidity 4. Specific preoperative therapy (hormonal treatment, chemotherapy, radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To evaluate the accuracy of 18F-FACBC PET/CT for preoperative lymph node staging in moderate to high risk prostate cancer patients who are already scheduled for prostatectomy and pelvic lymph node dissection;Secondary Objective: •To evaluate 18F-FACBC performance respect to standard clinical predictive factors of disease (e.g. age, psa, gleason score,tumor stage, choline PET/CT results). •To calculate 18F-FACBC sensitivity and specificity ;Primary end point(s): ?To evaluate the accuracy of 18F-FACBC PET/CT for preoperative lymph node staging in moderate to high risk prostate cancer patients who are already scheduled for prostatectomy and pelvic lymph node dissection;Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate 18F-FACBC performance respect to standard clinical predictive factors of disease (e.g. age, psa, gleason score,tumor stage, choline PET/CT results). • To calculate 18F-FACBC sensitivity and specificity ;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Italy
Contacts
Public ContactU.O. Medicina Nucleare P.I. Dr.ssa
AOU di Bologna Policlinico S.Orsola-Malpighi
Outcome results
None listed