Overview

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

Status:
Completed
Trial end date:
2019-04-25
Target enrollment:
0
Participant gender:
Male
Summary
This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Edetic Acid
Gallium 68 PSMA-11
Criteria
Inclusion Criteria:

- Histopathologically proven prostate cancer (PCa)

- Radical prostatectomy as definitive treatment for PCa

- Proven biochemical recurrence as defined by American Urological Association (AUA)
recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks
after radical prostatectomy

- PSA values ranging from 0.2 ng/mL to 2 ng/mL

- No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node
dissection)

- Axumin PET/CT scan already performed or scheduled as best standard of care procedure
for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11
PET/CT

- Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group
(ECOG)/World Health Organization [WHO] equivalent)

- Ability to understand a written informed consent document and the willingness to sign
it

Exclusion Criteria:

- Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan

- Unable to lie flat, still or tolerate a PET scan