Prostate CancerProstate Cancer (Adenocarcinoma)Fluorescence Imaging
Investigational drug(s) / intervention(s)
AS1986NS
AS1986NS: Single dose, IV, 100 µg of AS1986NS
Study summary
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
Eligibility
Sex
MALE
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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