64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)
brief summary
The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.
detailed description
Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen \[PSA\] reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy). Three independent, central readers blinded to the participant number, the time of the PET/CT scan, and the results of the conventional methodologies, assessed the 64Cu-SAR-BBN PET/CT. Three separate independent readers assessed the results of the conventional methodologies.
official title
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer