Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

a study on Prostate Cancer

Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Edward Uchio, MD, FACS, CPI (uci)

Description

Summary

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Official Title

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Keywords

Prostate Cancer, Prostatic Neoplasms, 64Cu-SAR-bisPSMA

Eligibility

You can join if…

Open to males ages 18 years and up

  • At least 18 years of age.
  • Signed informed consent.
  • Untreated, histologically confirmed adenocarcinoma of the prostate.
  • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
  • Patients electing to undergo RP with PLND.

You CAN'T join if...

  • Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  • Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  • Patients with known predominant small cell or neuroendocrine PC.

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • Urology Group of Southern California accepting new patients
    Los Angeles California 90017 United States
  • Greater Los Angeles VA Medical Center accepting new patients
    Los Angeles California 90073 United States
  • Stanford University Medical Center accepting new patients
    Stanford California 94305-5105 United States

Lead Scientist at University of California Health

  • Edward Uchio, MD, FACS, CPI (uci)
    Clinical Professor, Urology, School of Medicine. Authored (or co-authored) 88 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clarity Pharmaceuticals Ltd
ID
NCT06056830
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 383 study participants
Last Updated
Contact us about this trial