Trial Summary
What is the purpose of this trial?The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.
Eligibility Criteria
This trial is for men over 18 with biopsy-proven prostate adenocarcinoma, whose PSA levels have risen by at least 2 ng/ml after initial treatments like surgery or radiation. They must be able to undergo PET/CT scans and not have claustrophobia or other issues that would make such imaging difficult.Inclusion Criteria
You need to be able to undergo a PET/CT or PET/MR scan without any problems.
I had surgery or radiation (or both) as my first cancer treatment.
I was first treated with surgery or specific types of therapy for my condition.
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Exclusion Criteria
Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
Participant Groups
The study tests a new diagnostic agent called 68Ga-HBED-CC-PSMA in detecting recurrent prostate cancer on PET/CT scans, especially when PSA levels are low but rising, indicating potential cancer activity.
2Treatment groups
Active Control
Group I: Ga-HBED-iPSMA PET with CT or MRIActive Control3 Interventions
Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
Group II: Ga-HBED-iPSMA PET with MRIActive Control2 Interventions
Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Westchester (Consent only)Harrison, NY
Memoral Sloan Kettering Monmouth (Consent only)Middletown, NJ
Memoral Sloan Kettering Basking Ridge (Consent only)Basking Ridge, NJ
Memorial Sloan Kettering Monmouth (Consent only)Middletown, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor