NCT06907641 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
| NCT ID | NCT06907641 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St Vincent's Hospital, Sydney |
| Condition | Prostate Cancer (Post Prostatectomy) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-11-21 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: * 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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06907641 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Post Prostatectomy). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06907641 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06907641 currently recruiting?
Yes, NCT06907641 is actively recruiting participants. Contact the research team at svhs.nm@svha.org.au for enrollment information.
Where is the NCT06907641 trial being conducted?
This trial is being conducted at Darlinghurst, Australia.
Who is sponsoring the NCT06907641 clinical trial?
NCT06907641 is sponsored by St Vincent's Hospital, Sydney. The trial plans to enroll 50 participants.
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