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

Status

Withdrawn

Conditions

Prostate Nodule

Prostate Cancer

Treatments

Radiation: 18F-fluciclovine

Study type

Interventional

Funder types

Other

Identifiers

NCT05035732

2021-0146

NCI-2021-09407 (Other Identifier)

Details and patient eligibility

About

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

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.

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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