A Single-Arm, Blinded, Fluorescent PSMA… | Clinical Trial

Key information

Conditions

Prostate Cancer Adenocarcinoma Carcinoma Fluorescence Imaging Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostate Cancer (Adenocarcinoma) Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

HCA Florida Kendall Hospital, Miami, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AS1986NS

Drug

Single dose, IV, 100 µg of AS1986NS

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Wu, MD

CONTACT

[email protected]

917-960-8876

Sponsors and collaborators

Lead sponsor

Antelope Surgical Solutions, Inc

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 2, 2025
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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