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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2024-01-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Prostate Cancer Prostate Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-ACBC

Group Type EXPERIMENTAL

18F-fluciclovine

Intervention Type RADIATION

IV

Interventions

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18F-fluciclovine

IV

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes