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

Not Applicable

Withdrawn

• Conditions: Prostate Nodule; Prostate Cancer
• Interventions: Radiation: 18F-fluciclovine

• Registration Number: NCT05035732
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2021-03-25
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Status Verified: 2024-01
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-ACBC	18F-fluciclovine	-

Primary Outcome Measures

Name	Time	Method
To assess the diagnostic performance of 18F- Fluciclovine pelvic PET/MRI to that of pelvic mpMRI	through study completion, an average of 1 year