Clinical Trial · NCT02680041

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

Overview

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.

Sponsor

Blue Earth Diagnostics, LTD

Phase

Phase 3

Contacts

Peter Gardiner, MB ChB, MRCP, FFPM (STUDY_DIRECTOR)

Umar Mahmood, MD, PhD (STUDY_CHAIR)

ClinicalTrials.gov

NCT02680041

Eligibility

Inclusion

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.
Post prostatectomy: Detectable or rising PSA level that is \>0.2 ng/mL with a second confirmatory level of \>0.2 ng/mL
History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
Being considered for salvage therapy
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).
Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
Previous brachytherapy treatment will have occurred at least 2 years in the past

Exclusion

History of bilateral orchidectomy
Inability to tolerate 18F-fluciclovine PET/CT
Androgen deprivation therapy (ADT) in the past 3 months
Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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