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

Completed · Phase 2

Conditions studied: Recurrent Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT03515577

Run by

Jonsson Comprehensive Cancer Center

People needed

50

Starts

2019-04-12

Expected to finish

2019-04-25

Last updated by the study team

2020-10-14

Who can join

Age: 19 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan
• Unable to lie flat, still or tolerate a PET scan

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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