Fluorescence Imaging, Prostate Cancer, Prostate Cancer (Adenocarcinoma)
Conditions
Keywords
fluorescent agent, PSMA, prostate surface membrane antigen, histopathology, fluorescence-guided surgery
Brief summary
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Interventions
DRUGAS1986NS
Single dose, IV, 100 µg of AS1986NS
Sponsors
Antelope Surgical Solutions, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AS1986NS | 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 |
Countries
United States
Contacts
CONTACTAmy Wu, MD
Outcome results
None listed