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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorClarity Pharmaceuticals Ltd

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 64Cu-SAR-bisPSMA

Treatment groups

383 Participants
are divided into 1 treatment group

Sponsors and collaborators