Recruiting
Phase 1
Phase 2

AS1986NS

Sponsor:

Antelope Surgical Solutions, Inc

Code:

NCT06906471

Conditions

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Fluorescence Imaging

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AS1986NS

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Fluorescence Imaging

Study ID

NCT06906471

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single dose of AS1986NS

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

Interventions

AS1986NS

Single dose, IV, 100 µg of AS1986NS

Primary outcome measure

  • Safety of AS1986NS [ Time Frame: Enrollment to 30 days post single infusion ]

Central Contacts and Locations

Central contacts

Amy Wu, MD

917-960-8876info@antelopesurgical.com

Locations

HCA Florida Kendall Hospital

Recruiting

Miami, Florida, United States, 33175

Contacts

Shirin Razdan, MD

305-468-3314srazdan@miamiroboticsurgery.com

More Information

Sponsor

Antelope Surgical Solutions, Inc

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • fluorescent agent
  • PSMA
  • prostate surface membrane antigen
  • histopathology
  • fluorescence-guided surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Antelope Surgical Solutions, Inc on 2026-07-09.