Status:
COMPLETED
Evaluation of PSMA Antagonist Produced by Two Different Methods
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Metastatic Prostate Adenocarcinoma
Eligibility:
MALE
21-100 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET) scans within 24-48 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04685811
Start Date
December 9 2020
End Date
June 30 2021
Last Update
September 22 2022
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10021