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
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-11-21
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer
NCT06970847
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
NCT04839367
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer
NCT05286840
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
NCT06056830
Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer
NCT06235099
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
64Cu-SAR-bisPSMA
200MBq 64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA
All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
64Cu-SAR-bisPSMA
All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clarity Pharmaceuticals Ltd
INDUSTRY
St Vincent's Hospital, Sydney
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Louise Emmett
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CT-2024-CTN-06035-1
Identifier Type: OTHER
Identifier Source: secondary_id
CLP11 (Co-PSMA)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.