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Clinical Trial · NCT03689582
Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer
Overview
The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.
Sponsor
University of Michigan Rogel Cancer Center
Phase
Phase 2
Contacts
Morand R Piert, M.D. (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03689582Drug / Compound
PSMA-11
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Eligibility
Inclusion
- Treating physician has already indicated a need for a prostate biopsy procedure.
- Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
- Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.
Exclusion
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
- Unable to lie flat, still, or tolerate a PET/CT scan
- Inability or unwillingness to receive a prostate biopsy procedure
- Unable to provide own consent
- Prostate biopsy within 12 weeks before enrollment
- Acute prostatitis within the last 6 months
- Body weight greater than 350 lbs (158 Kg)
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