Comparing two imaging techniques for detecting prostate cancer recurrence after surgery
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
This study is testing whether a new type of PET scan can find more signs of prostate cancer returning after surgery compared to the standard scan in men who have had a rise in their cancer markers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | St Vincent's Hospital, Sydney Academic / other |
| Locations | 1 site (Darlinghurst, New South Wales) |
| Trial ID | NCT06907641 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of 64Cu-SAR-bisPSMA PET/CT and 68Ga PSMA-11 PET/CT scans in detecting prostate cancer recurrence in men who have experienced biochemical failure following radical prostatectomy. Participants will undergo three visits, including standard imaging and additional scans to evaluate the diagnostic accuracy and potential changes in clinical management. The study seeks to determine if the new imaging technique can detect more lesions and improve patient outcomes compared to the standard method.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 or older who have undergone radical prostatectomy for prostate cancer and are experiencing rising PSA levels without prior salvage radiotherapy.
Not a fit: Patients who have had prior salvage radiotherapy or have contraindications to the imaging agents will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of prostate cancer recurrence, allowing for more effective treatment strategies.
How similar studies have performed: Other studies have shown promising results with similar imaging techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Darlinghurst, New South Wales
- St Vincent's Hospital, Sydney — Darlinghurst, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Sobia Khan, MBBS, FRACP
- Email: svhs.nm@svha.org.au
- Phone: +61 0283821830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.