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NCT06906471PHASE1, PHASE2Recruiting

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

Antelope Surgical Solutions, Inc

Start Date

7/1/2026

Completion Date

12/30/2026

Summary

A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS

Eligibility Criteria

Age Range: 18 years to 90 years

Inclusion Criteria: * suspected prostate cancer warranting standard of care multi-core prostate biopsy Exclusion Criteria: * Patients receiving same-day therapeutic Lutetium-177 or Actinium-225 PSMA receptor radiation isotope therapy treatment * Patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature * Patients with a creatinine clearance cutoff (CrCl) of \< 60 mL/min

Interventions

DRUG

AS1986NS

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Conditions

Prostate CancerProstate Cancer (Adenocarcinoma)Fluorescence Imaging

Locations

HCA Florida Kendall Hospital

Miami, Florida 33175

United States

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York 10029

United States