Status:
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
Lead Sponsor:
St Vincent's Hospital, Sydney
Collaborating Sponsors:
Clarity Pharmaceuticals Ltd
Conditions:
Prostate Cancer (Post Prostatectomy)
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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:...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06907641
Start Date
November 21 2024
End Date
November 1 2025
Last Update
April 2 2025
Active Locations (1)
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1
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia, 2010