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

Launched by JONSSON COMPREHENSIVE CANCER CENTER · May 2, 2018

Keywords

ClinConnect Summary

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), c...

Gender

MALE

Eligibility 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