NCT06906471

Brief Summary

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
2mo left

Started Feb 2026

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

March 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

March 18, 2025

Last Update Submit

January 20, 2026

Conditions

Prostate Cancer (Adenocarcinoma)Prostate CancerFluorescence Imaging

Keywords

fluorescent agentPSMAprostate surface membrane antigenhistopathologyfluorescence-guided surgery

Outcome Measures

Primary Outcomes (1)

  • Safety of AS1986NS

    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

Study Arms (1)

Single dose of AS1986NS

EXPERIMENTAL

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

Drug: AS1986NS

Interventions

AS1986NSDRUG

Single dose, IV, 100 µg of AS1986NS

Single dose of AS1986NS

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suspected prostate cancer warranting standard of care multi-core prostate biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HCA Florida Kendall Hospital

Miami, Florida, 33175, United States

Location

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029, United States

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333, Taiwan

Location

Related Publications (3)

  • Kommidi H, Guo H, Nurili F, Vedvyas Y, Jin MM, McClure TD, Ehdaie B, Sayman HB, Akin O, Aras O, Ting R. 18F-Positron Emitting/Trimethine Cyanine-Fluorescent Contrast for Image-Guided Prostate Cancer Management. J Med Chem. 2018 May 10;61(9):4256-4262. doi: 10.1021/acs.jmedchem.8b00240. Epub 2018 Apr 20.

    PMID: 29676909BACKGROUND

  • Guo H, Kommidi H, Vedvyas Y, McCloskey JE, Zhang W, Chen N, Nurili F, Wu AP, Sayman HB, Akin O, Rodriguez EA, Aras O, Jin MM, Ting R. A Fluorescent, [18F]-Positron-Emitting Agent for Imaging Prostate-Specific Membrane Antigen Allows Genetic Reporting in Adoptively Transferred, Genetically Modified Cells. ACS Chem Biol. 2019 Jul 19;14(7):1449-1459. doi: 10.1021/acschembio.9b00160. Epub 2019 Jun 17.

    PMID: 31120734BACKGROUND

  • Aras O, Demirdag C, Kommidi H, Guo H, Pavlova I, Aygun A, Karayel E, Pehlivanoglu H, Yeyin N, Kyprianou N, Chen N, Harmsen S, Sonmezoglu K, Lundon DJ, Oklu R, Ting R, Tewari A, Akin O, Sayman HB. Small Molecule, Multimodal, [18F]-PET and Fluorescence Imaging Agent Targeting Prostate-Specific Membrane Antigen: First-in-Human Study. Clin Genitourin Cancer. 2021 Oct;19(5):405-416. doi: 10.1016/j.clgc.2021.03.011. Epub 2021 Mar 19.

    PMID: 33879400BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsAdenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Amy Wu, MD

CONTACT

917-960-8876info@antelopesurgical.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 2, 2025

Study Start

February 1, 2026

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

TW(1)US(2)