Evaluation of PSMA Antagonist Produced by Two Different Methods

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Edetic Acid; Gallium 68 PSMA-11

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.