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

Prospective Single Center Trial to Compare 68Ga-PSMA-11 and Axumin PET/CT (18F-Fluciclovine) for Restaging Prostate Cancer Patients With Biochemical Recurrence After Radical Prostatectomy

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.

PRIMARY OBJECTIVES:

I. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and region based analysis.

SECONDARY OBJECTIVES:

I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT, stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).

II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up.

III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.

OUTLINE:

Participants receive (68)Ga-PSMA-11 intravenously (IV) and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.

After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up to 12 months.

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