Health Trials

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

ConditionsProstate CancerProstatic Neoplasms
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

Locations

31
Australia
St. Vincent's Sydney SydneyNew South Wales, Australia
Princess Alexandra Hospital WoolloongabbaQueensland, Australia
Fiona Stanley Hospital6150, MurdochWestern Australia, Australia
Puerto Rico
Pan American Center for Oncology Trials, LLC - Ciudadela00918, San Juan Puerto Rico

Sponsors and collaborators

Clarity Pharmaceuticals Ltd

Lead sponsor

Source ClinicalTrials.gov