NCT06907641CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 26 Mar 2025
- Start date
- Nov 2024
- Primary completion date
- Sept 2025
- Lead sponsor
- St Vincent's Hospital, Sydney
- Diseases
- Prostate cancer
- NCT number
- NCT06907641
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From Nov 2024 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.