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

Sponsor: Clarity Pharmaceuticals Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06056830

Patient View

This clinical trial evaluates the diagnostic accuracy of 64Cu-SAR-bisPSMA PET in detecting nodal metastases in high-risk prostate cancer patients. Eligible participants are adults with untreated, confirmed adenocarcinoma, meeting specific high-risk criteria, and planning radical prostatectomy with lymph node dissection. Exclusions include recent high-energy radioisotope use and hypersensitivity to the drug. Participants receive a single 200MBq 64Cu-SAR-bisPSMA injection.

Patient Parameters

Program Overview

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

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

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