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

Antelope Surgical Solutions, Inc

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Fluorescence Imaging; Prostate Cancer (Adenocarcinoma); Prostate Cancer

Treatments: Drug: AS1986NS

Study type: Interventional

Funder types: Industry

Identifiers

NCT06906471

173786_007_1

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single dose of AS1986NS

Experimental group

Description:

Single dose of AS1986NS administered as an injection through peripheral intravenous access.

Treatment:

Drug: AS1986NS