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 (Co-PSMA)

St Vincent's Hospital, Sydney

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer (Post Prostatectomy)

Treatments: Drug: 64Cu-SAR-bisPSMA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06907641

CLP11 (Co-PSMA)

CT-2024-CTN-06035-1 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

64Cu-SAR-bisPSMA

Experimental group

Description:

200MBq 64Cu-SAR-bisPSMA

Treatment:

Drug: 64Cu-SAR-bisPSMA