Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Post Prostatectomy) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-SAR-bisPSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 64Cu-SAR-bisPSMA
- description
- 200MBq 64Cu-SAR-bisPSMA
- interventionNames
- Drug: 64Cu-SAR-bisPSMA
Primary outcomes (1)
- measure
- Detection rate of lesions per participants, between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT
- timeFrame
- 12 months
- description
- 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 outcomes (6)
- measure
- Compare the number of lesions outside of the prostatic fossa per patient between 64Cu-SAR-bisPSMA and 68Ga PSMA-11 PET/CT.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKhan 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. PMID 41904043