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

Blue Earth Diagnostics

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: 18F-fluciclovine PET CT

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02680041

BED003

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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