18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:June 1, 2016
End Date:November 1, 2017

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The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment

This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent
prostate cancer after curative-intent primary therapy and negative or equivocal findings on
standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine
PET/CT. Site clinicians will manage study subjects per standard practices and will document
any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants
will be followed for up to 6 months, with clinical data collected for this study. An
interdisciplinary panel will provide expert guidance to local readers on request. The final
reporting of the PET/CT scan will be a single report by the local reader following any such
discussion.


Inclusion Criteria:

- History of histologically confirmed adenocarcinoma of the prostate post
curative-intent local treatment (radical prostatectomy, local radiotherapy,
brachytherapy).

- Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy
for organ confined disease defined as :

- Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second
confirmatory level of >0.2 ng/mL

- Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir

- Negative or equivocal findings on standard-of-care imaging for restaging of disease in
the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT;
and either CT or MRI of the pelvis (or the abdomen and pelvis).

- Being considered for salvage therapy

- Any non-surgical local treatment such as previous cryotherapy, external beam
radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.

- Previous brachytherapy treatment will have occurred at least 2 years in the past

- Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

- Ongoing treatment with any systemic therapy intended for the treatment of prostate
cancer (e.g., antiandrogen or LHRH agonist or antagonist)

- Androgen deprivation therapy (ADT) in the past 3 months

- History of bilateral orchidectomy

- Inability to tolerate 18F-fluciclovine PET/CT
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