AS1986NS for Prostate Cancer Imaging

This study is testing a drug called AS1986NS to see if it's safe for people with suspected prostate cancer. AS1986NS is given through an IV (intravenous, meaning into a vein). The study aims to enroll 10 men, aged 18 to 90, who are scheduled for a prostate biopsy. You cannot join if you are receiving certain radiation treatments or have severe problems with your liver, kidneys, or heart. The main goal is to check the safety of AS1986NS for up to 30 days after you receive it. The current recruitment status is unclear.

Study design
This is a single-arm, blinded study, meaning all participants receive the same intervention, and you won't know if you're getting the active drug or a placebo. It plans to include 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from enrollment up to 30 days after receiving the single infusion of AS1986NS.

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NCT06906471

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

Recruiting
PHASE1Ages 18–90InterventionalDiagnostic
Antelope Surgical Solutions, Inc
~10 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:AS1986NS

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of AS1986NS
Measured over Enrollment to 30 days post single infusion
Prostate Cancer
Prostate Cancer (Adenocarcinoma)
Fluorescence Imaging
2 sites across 2 states
Florida1
New York1

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Safety of AS1986NSEnrollment 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