A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- M.D. Anderson Cancer Center
- Primary Endpoint
- To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male patients who are 18 years and older
- •Histologically or cytologically proven prostate carcinoma s/p definitive radiation
- •Patients suspected to have BCR based on phoenix criteria (prostate specific antigen value (PSA) of 2 ng/mL above the PSA nadir)
- •Ability to understand and willingness to sign informed consent
Exclusion Criteria
- •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.
- •Patients with contraindication to undergo MRI
- •Patients with prior allergy to MRI contrast agent.
- •Extreme Claustrophobia
Outcomes
Primary Outcomes
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI
Time Frame: through study completion, an average of 1 year