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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer (Post Prostatectomy)

In brief

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

Key facts

Study ID

NCT06907641

Run by

St Vincent's Hospital, Sydney

People needed

50

Starts

2024-11-21

Expected to finish

2025-11-01

Last updated by the study team

2025-04-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patients aged 18 or above
• Ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study.
• Prior radical prostatectomy for confirmed adenocarcinoma on histopathology.
• Rising PSA (0.20 - 0.75 ng/mL) following radical prostatectomy with no prior salvage radiotherapy.
• 68Ga PSMA-11 PET/CT within the last 4 weeks for prostate cancer biochemical recurrence.

You may not qualify if…

• Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
• History of current active malignancy as per investigator discretion other than prostate cancer.
• Known or expected hypersensitivity to 64Cu-SAR-bisPSMA
• Systemic therapy for metastatic prostate cancer including androgen deprivation therapy.

Where it is running

• St Vincent's Hospital, Sydney — Darlinghurst, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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