TheranosticTrials.org

Clinical Trial · NCT05286840

64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer

Overview

This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Tony Romero (CONTACT)

tromero@gucancer.com

402-697-2229

ClinicalTrials.gov

NCT05286840

Drug / Compound

SAR-bisPSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: SarAr

Eligibility

Inclusion

  • Adequate recovery from acute toxic effects of any prior therapy.
  • Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
  • Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)
  • The Eastern Cooperative Oncology (ECOG) performance status 0-2.

Exclusion

  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
  • Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
  • Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.