Phase 2
Completed N=16
Evaluation of PSMA Antagonist Produced by Two Different Methods
Metastatic Prostate Adenocarcinoma
Source: ClinicalTrials.gov NCT04685811 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions — 0.98; 0.98; 0.99; 0.99 ICC estimate
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions |
0.98; 0.98; 0.99; 0.99; 0.97 | — |
| PRIMARY Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Average SUV Max-pathologic Regions |
0.96; 0.86; 0.70; 0.82 | — |
| PRIMARY ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax |
0.97 | — |
| SECONDARY Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -Pathologic Regions |
0.59; 0.91; 0.78 | — |
| SECONDARY Compare Bio-Distribution Between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator |
0.97; 0.94; 0.97; 0.71 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04685811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.