Actively Recruiting
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
Led by St Vincent's Hospital, Sydney · Updated on 2025-04-02
50
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
S
St Vincent's Hospital, Sydney
Lead Sponsor
C
Clarity Pharmaceuticals Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 or above
- Ability to provide informed consent and willingness to participate
- Prior radical prostatectomy confirming adenocarcinoma
- Rising PSA between 0.20 and 0.75 ng/mL after prostatectomy with no prior salvage radiotherapy
- 68Ga PSMA-11 PET/CT performed within the last 4 weeks for biochemical recurrence
You will not qualify if you...
- Prior or contraindicated salvage radiotherapy for recurrent prostate cancer
- Current active malignancy other than prostate cancer as determined by the investigator
- Known or expected allergy to 64Cu-SAR-bisPSMA
- Use of systemic therapy for metastatic prostate cancer including androgen deprivation therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
Research Team
S
Sobia Khan, MBBS, FRACP
CONTACT
L
Louise Emmett, MBChB, FRACP, MD, FAANMS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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