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.

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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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT05035732

Recruitment Status:

Not yet recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Devaki Surasi, MD
Contact
713-792-6536
[email protected]
Devaki Surasi, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT05035732

Recruitment Status:

Not yet recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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