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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Blue Earth Diagnostics
• Collaborators: American College of Radiology; IND 2 Results LLC; Syne Qua Non Limited

Criteria

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