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Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy

NCT06907641 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-02

No results posted yet for this study

Summary

The goal of this clinical trial is to compare 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT in men with biochemical failure following radical prostatectomy. The main questions it aims to answer are:

* Is there a difference in the number of lesions of prostate cancer recurrence detected between the 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans.
* What is the diagnostic accuracy of 64Cu-SAR-bisPSMA PET/CT compared to 68Ga PSMA-11 PET/CT using a standard of care comparator.
* Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11).

Participants will:

* have 3 visits: 1) standard of care 68Ga PSMA-11 dose and PET/CT scan; 2) 64Cu-SAR-bisPSMA dose and PET/CT; 3) 64Cu-SAR-bisPSMA PET/CT only
* have standard of care blood test either at Visit 1 or Visit 2

Conditions

  • Prostate Cancer (Post Prostatectomy)

Interventions

DRUG

64Cu-SAR-bisPSMA

All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA

Sponsors & Collaborators

  • Clarity Pharmaceuticals Ltd

    collaborator INDUSTRY

  • St Vincent's Hospital, Sydney

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907641 on ClinicalTrials.gov