A Prospective Pilot Study for the Evaluation of 18F- Fluciclovine PET/MRI in Radio-recurrent Prostate Cancer (RRPC-PET/MRI Study)

M.D. Anderson Cancer Center

Overview

To perform both PET scans and MRIs in the same setting using a simultaneous PET/MRI scanner.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Prostate Cancer Prostate Nodule

Interventions

18F-fluciclovineRADIATION

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Data from ClinicalTrials.gov

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