Ga-68 PSMA PET/CT for Prostate Cancer
Trial Summary
What is the purpose of this trial?
This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.
Research Team
Michael M Graham, Ph.D., MD
Principal Investigator
University of Iowa
Eligibility Criteria
This trial is for men with prostate cancer that has returned after surgery or radiation therapy. They must have a specific level of PSA, a protein linked to prostate cancer, in their blood and be generally healthy without other recent cancers (except certain skin or superficial bladder cancers). Participants can't join if they're taking experimental drugs, allergic to sulfa medications, have heart problems, uncontrolled illnesses, or conditions affecting study compliance.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants receive an injection of Ga-68 PSMA and undergo a PET scan to identify prostate cancer
Follow-up
Participants are monitored for safety and effectiveness of the imaging results, with clinical follow-up and additional imaging as needed
Optional Second Imaging
Participants may be invited for a second 68Ga PSMA scan if initial results show positive lymph nodes or metastases
Treatment Details
Interventions
- Ga-68 PSMA-HBED-CC PET
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Who Is Running the Clinical Trial?
Michael Graham PhD, MD
Lead Sponsor