Clinical trial · Interventional
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer: A Prospective, Non-randomized, Single Arm, Single Center, Open-label Phase 1/2 Study
NCT05286840CI-TRIAL-00057202unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-SAR-bisPSMA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess safety of 64Cu-SAR-bisPSMA (all patients).
- timeFrame
- From injection of 64Cu-SAR-bisPSMA to one week following.
- description
- To assess treatment emergent adverse events.
Secondary outcomes (3)
- measure
- Disease status adjustment (patients with suspected disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
- timeFrame
- Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
- description
- Disease status will be assessed before and after 64Cu-SAR-bisPSMA PET/CT Imaging.
- measure
- Disease Staging adjustment (for patients with known disease at entry) before vs after 64Cu-SAR-bisPSMA PET/CT Imaging.
- timeFrame
- Within one week of 64Cu-SAR-bisPSMA PET/CT Imaging
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed an informed consent. 2. \>18 years of age. 3. Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy. 4. The Eastern Cooperative Oncology (ECOG) performance status 0-2. 5. Adequate recovery from acute toxic effects of any prior therapy. 6. Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher) Exclusion Criteria: 1. Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration. 2. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration. 3. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. 4. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.