Prostate Cancer (Post Prostatectomy)
Conditions
Keywords
Prostate Cancer, Salvage Radiotherapy, Prostatectomy, Co-PSMA, CLP11, Prostate Cancer Recurrence, Biochemical Failure, Radical Prostatectomy, Copper, PET scan
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
Interventions
DRUG64Cu-SAR-bisPSMA
All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
Sponsors
St Vincent's Hospital, Sydney
Clarity Pharmaceuticals Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 (biopsy, concurrent imaging and response to targeted therapy). |
| 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 | — |
Countries
Australia
Outcome results
None listed