Prostate Cancer Clinical Trial
A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)
Summary
This study will 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.
Full 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.
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
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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