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

Purpose

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

Conditions

  • Prostate Cancer
  • Prostate Cancer (Adenocarcinoma)
  • Fluorescence Imaging

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single dose of AS1986NS 		Single dose of AS1986NS administered as an injection through peripheral intravenous access.
  • Drug: AS1986NS
    Single dose, IV, 100 µg of AS1986NS

Recruiting Locations

HCA Florida Kendall Hospital
Miami, Florida 33175
Contact:
Shirin Razdan, MD
305-468-3314
srazdan@miamiroboticsurgery.com

More Details

Status
Recruiting
Sponsor
Antelope Surgical Solutions, Inc

Study Contact

Amy Wu, MD
917-960-8876
info@antelopesurgical.com