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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 64Cu-SAR-bisPSMA.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Post Prostatectomy). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug 64Cu-SAR-bisPSMA
All participants will receive a single administration of 200 MBq of 64Cu-SAR-bisPSMA
Primary outcome measures
- Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT [Time frame: 12 months]
Secondary outcome measures (6)
- Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT. [Time frame: 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 [Time frame: 12 months]
- Evaluate the magnitude of clinical management change when using 64Cu-SAR-bisPSMA additional to standard of care imaging (68Ga PSMA-11). [Time frame: 12 months]
- Compare the total number of lesions between 1 to 4-hour, and 24-hour 64Cu-SAR-bisPSMA PET/CT imaging timepoints. [Time frame: 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 [Time frame: 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. [Time frame: 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Australia · 1 center
- St Vincent's Hospital, Sydney — Darlinghurst
Publications
- 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- PMID 41904043
Identifiers
NCT: NCT06907641 · CLP11 (Co-PSMA) · CT-2024-CTN-06035-1