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

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02680041

Run by

Blue Earth Diagnostics

People needed

221

Starts

2016-06-01

Expected to finish

2017-11-01

Last updated by the study team

2019-01-28

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Tower Urology — Los Angeles, California, United States
• Genesis Research, LLC — San Diego, California, United States
• University of Florida — Jacksonville, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Roudebush VA Medical Center — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Coastal Urology Associates — Brick, New Jersey, United States
• Manhattan Medical Research — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Urologic Consultants of SE Pennsylvania — Bala-Cynwyd, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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