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

June 2, 2026 updated by: Antelope Surgical Solutions, Inc
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taoyuan City, Taiwan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Po-Hung Lin, MD
  • United States
    • Florida
      • Miami, Florida, United States, 33175
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai (ISMMS)
        • Contact:
        • Principal Investigator:
          • Ashutosh Tewari, MBBS, MCh, FRCS (Hon)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of AS1986NS
Time Frame: Enrollment to 30 days post single infusion
Demonstrate that AS1986NS is 'safe' as a microdosed <100 µg, <100 µL, 1 mg/mL per patient dose when introduced intravenously as a bolus through peripheral intravenous access by evaluation of the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with AS1986NS
Enrollment to 30 days post single infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antelope Surgical Solutions, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 5, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173786_007_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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