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Taking people in AustraliaPhase 3

PET Scan Test for Spread of High-risk Prostate Cancer to Lymph Nodes

Tests a PET scan tracer to detect prostate cancer spread to lymph nodes in adults.

Plain-language title generated from the registry record
Registry title: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Key facts

Where
Murdoch, Nedlands, Sydney, and Woolloongabba, AustraliaSee the 4 sites
Phase
Phase 3

Where in Australia

  • Fiona Stanley HospitalMurdoch, AustraliaTaking people
  • RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private HospitalNedlands, AustraliaTaking people
  • St. Vincent's SydneySydney, AustraliaTaking people
  • Princess Alexandra HospitalWoolloongabba, AustraliaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Clarity Pharmaceuticals Ltd
Trial code
NCT06056830
Record updated
11 September 2026
Original description
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.Read full original descriptionShow less

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

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

Inclusion: 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: 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.

ClinicalTrials.gov NCT06056830