Prostate Cancer, Prostate Nodule
Conditions
Brief summary
To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.
Detailed description
Primary Objective: --To compare the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI and to determine whether 18F- Fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic RRPC in men with biochemical recurrence with histopathology as reference standard. Secondary Objective: --To study inter-reader reliability of 18F- Fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers. Exploratory Objective: --To study correlation between SUVmax and ADCmean in the pelvic RRPC.
Interventions
RADIATION18F-fluciclovine
IV
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male patients who are 18 years and older 2. Histologically or cytologically proven prostate carcinoma s/p definitive radiation 3. Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir) 4. Ability to understand and willingness to sign informed consent
Exclusion criteria
1. Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements. 2. Patients with contraindication to undergo MRI 3. Patients with prior allergy to MRI contrast agent. 4. Extreme Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI | through study completion, an average of 1 year |
Outcome results
None listed