Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CT-2024-CTN-06035-1 | Other Identifier | Therapeutic Goods Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clarity Pharmaceuticals Ltd | INDUSTRY |
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64Cu-SAR-bisPSMA | Experimental | 200MBq 64Cu-SAR-bisPSMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-SAR-bisPSMA | Drug | All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT | Compare the detection rate of sites of prostate cancer recurrence, as determined by number of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT in patients with biochemical recurrence following radical prostatectomy who are being considered for curative salvage radiotherapy. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT. | 12 months | |
| Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male patients
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sobia Khan, MBBS, FRACP | Contact | +61 0283821830 | svhs.nm@svha.org.au | |
| Louise Emmett, MBChB, FRACP, MD, FAANMS | Contact | +61 0283821830 | louise.emmett@svha.org.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital, Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41904043 | Derived | Khan S, Papa N, Kneebone A, Eade T, Ayati N, Nguyen A, Wong K, Chen J, Ho B, Idiare J, Sidhom G, Roberts MJ, Thompson J, Sharma S, Weir S, Devitt K, Kooner R, Lieng H, Rasiah K, Olphert J, de Leon J, Hruby G, Stricker P, Emmett L. Prospective Comparison of 64Copper [64Cu]SAR-bisPSMA vs 68Gallium[68Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial). Eur Urol. 2026 Jun;89(6):512-520. doi: 10.1016/j.eururo.2026.03.001. Epub 2026 Mar 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the diagnostic accuracy of 64Cu-SAR-bisPSMA versus 68Ga PSMA-11 PET/CT in the detection of recurrent or metastatic prostate cancer using a composite standard of truth (biopsy, concurrent imaging and response to targeted therapy).
| 12 months |
| Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). | 12 months |
| Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints. | 12 months |
| Evaluate the frequency of prostatic fossa recurrence on the 24-hour 64Cu-SAR-bisPSMA images compared to the 1 to 4-hour 64Cu-SAR-bisPSMA and 1-hour 68Ga PSMA-11 PET/CT images | 12 months |
| Evaluate biochemical (PSA) response following salvage radiotherapy by 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT imaging parameters in the presence of normal testosterone levels. | 12 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided