A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-90
SponsorAntelope Surgical Solutions, Inc
About this trial
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
suspected prostate cancer warranting standard of care multi-core prostate biopsy
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
AS1986NS
DrugSingle dose, IV, 100 µg of AS1986NS
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single dose of AS1986NSExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Enrollment to 30 days post single infusionSponsors and contacts
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Source ClinicalTrials.gov
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