Phase 1 and 2 Study of AS1986NS Injection for Fluorescent Imaging in Men with Suspected Prostate Cancer

What this Trial Is About

This trial evaluates a single-arm, blinded histopathology study of AS1986NS, a fluorescent agent, in men suspected of having prostate cancer. The study focuses on prostate cancer adenocarcinoma and uses fluorescence imaging to assess the diagnostic potential of AS1986NS. The research is sponsored by Antelope Surgical Solutions, Inc and is conducted as a phase 1 and 2 interventional trial. Participants receive one single intravenous injection of 100 micrograms of AS1986NS through peripheral intravenous access. The study does not include a comparison group and is designed to monitor the safety of this single dose. The primary purpose is diagnostic, so the trial focuses on the performance of AS1986NS in imaging and histopathology. During the study, participants are observed from enrollment until 30 days after the infusion to monitor safety outcomes. The main measure is the safety of AS1986NS during this period. Participants will undergo standard prostate biopsy as part of routine care, with additional imaging and assessments related to the study treatment. The total participation lasts around one month post-infusion.

A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS