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64Cu-SAR-bisPSMA PET for High-Risk Prostate Cancer

This study is testing a new imaging method called 64Cu-SAR-bisPSMA PET to see how well it can find prostate cancer that has spread to nearby lymph nodes. This is for men with high-risk prostate cancer who are planning to have surgery to remove their prostate (radical prostatectomy) and lymph nodes. You could join if you are at least 18 years old, have untreated prostate cancer, and meet specific high-risk criteria. The study will measure how accurately the 64Cu-SAR-bisPSMA PET scan can detect these cancer cells. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 383 participants. It is not specified if it is randomized or blinded.
What's involved
All patients will receive a single injection of 200MBq 64Cu-SAR-bisPSMA.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured up to 16 weeks after the intervention.

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NCT06056830

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

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Clarity Pharmaceuticals Ltd
~383 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:64Cu-SAR-bisPSMA

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Measured over Up to 16 weeks

Conditions

Prostate Cancer
Prostatic Neoplasms

Explore related trials

Prostate Carcinoma

Where it's being run

31 sites across 24 states
California4
Texas3
Florida2
Michigan2
Alabama1
Arizona1
Arkansas1
Illinois1

Study leadership

  • Clarity Pharmaceuticals · STUDY_DIRECTOR · Clarity Pharmaceuticals

Who to contact

Clarity Pharmaceuticals
[email protected]
+61 (0) 2 9209 4037
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Eligibility criteria

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.

What this trial measures

  • Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastasesUp to 16 weeks

    Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.