NCT02680041
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
PHASE3
COMPLETED
NCT02680041
INTERVENTIONAL
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
Prostate Cancer
- DIAGNOSTIC
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- Type: DRUG
- Name: 18F-fluciclovine PET CT
- Description: Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
- Arm Group Labels: 18F-fluciclovine PET CT
- Blue Earth Diagnostics