Clinical trial · Interventional
Evaluation of PSMA Antagonist Produced by Two Different Methods
Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods
NCT04685811CI-TRIAL-00060991completedPhase 1 / Phase 2Results postedClinicalTrials.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)
Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.
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 |
|---|---|---|---|
| Metastatic Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
- description
- Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers.
- interventionNames
- Drug: 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
Primary outcomes (3)
- measure
- Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions
- timeFrame
- 2 study visits between 24 to 48 hours apart
- description
- Single score Intraclass Correlation Coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying pathologic lesions. The ICC, based on a one-way random effects model was used to assess reliability. The ICC ratios in this data shows the top five lesions with the greatest PSMA uptake (SUV) in each patient. This is a measure of the variance of interest (for the patient's lesion) over the total variance (from all data points for that particular lesion of interest). Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The lesions reported in this analysis range from the SUV of reference organs to the average SUV of a metastatic deposit. These scans were also performed within 48 hours of each other to limit heterogeneity that may correspond to disease progression or PSMA avidity.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study: * Aged 21 years or older and below 80 years of age * Signed written informed consent and willingness to comply with protocol requirements * Histologically confirmed diagnosis of metastatic prostate cancer * Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET Exclusion Criteria: * Laboratory values: * Serum creatinine \>2.5 mg/dL * AST (SGOT) \>2.5x ULN * Bilirubin (total) \>1.5x ULN * Serum calcium \>11 mg/dL * Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject. * Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements. * Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
References
Publications (0)
Data not yet available
No reference posted for this study.