None listed
Conditions
Brief summary
Exendin PET scans are special nuclear medicine imaging scans. These scans can detect cancers whose cells have a chemical, called the GLP1 receptor, on their surfaces. However, we are unaware of any reports of the use of Exendin PET scanning in prostate cancer. The purpose of this study is to determine if prostate cancer can be detected by Exendin PET scans. Who is it for? You may only be eligible for this study if you have metastatic castrate-resistant prostate cancer and have already been identified as potentially suitable for the study by our research team. Study details The study will assess whether PET scans using the chemical called Exendin can detect metastatic prostate cancer. Participants will have had a PET scan using the chemical PSMA (which is the usual type of PET scan used to detect prostate cancer) within the preceding 2 weeks. They will then have a single Exendin PET/CT scan at a major hospital. The procedure will involve: a) Injecting the study chemical (called [68Ga]-DOTA-Exendin) into an arm vein. b) Finger prick glucose testing to confirm participant blood sugar levels. c) An Exendin PET scan 60 minutes after the chemical injection. We hope this will demonstrate that prostate cancers can be detected by Exendin PET scans. If we can demonstrate that, we will have confirmed that prostate cancers bear GLP1 receptor.
Interventions
Men with metastatic castrate resistant prostate cancer (mCRPC), who have disease demonstrated by PSMA (prostate specific membrane antigen) PET/CT scan will, within 2 weeks of their positive PSMA PET/CT scan, each have a single Exendin PET/CT scan to see whether the Exendin PET/CT scanning can detect mCRPC.
Details of the Exendin PET/CT scan are as follows.
Radiopharmaceutical: [68Ga]-DOTA-Exendin4.
Activity: 68Ga: 2.6 MBq/kg, maximum peptide administered 20ug/patient
Injected: Intravenously o
Men with metastatic castrate resistant prostate cancer (mCRPC), who have disease demonstrated by PSMA (prostate specific membrane antigen) PET/CT scan will, within 2 weeks of their positive PSMA PET/CT scan, each have a single Exendin PET/CT scan to see whether the Exendin PET/CT scanning can detect mCRPC. Details of the Exendin PET/CT scan are as follows. Radiopharmaceutical: [68Ga]-DOTA-Exendin4. Activity: 68Ga: 2.6 MBq/kg, maximum peptide administered 20ug/patient Injected: Intravenously over 30 seconds via a peripheral cannula. Patient status prior to injection: Well hydrated (orally) and not fasting, and having had baseline finger prick blood sugar confirming not hypoglycaemic and 2nd peripheral cannula in situ in case intravenous glucose is required after injection to maintain blood glucose. Monitoring: Finger prick blood glucose measurements Scan Acquisition: At least 60 minutes after injection and having voided prior to scanning. Scanning location: Department of Cancer Imaging in a major cancer hospital Scan supervision: Nuclear physician
Sponsors
Mark S Stein Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Metastatic castrate resistant prostate cancer (mCRPC) 2) A history of radical prostatectomy 3) More than one lesion on a PSMA PET scan performed in The Department of Cancer Imaging of The Peter MacCallum Cancer Centre, Melbourne, Australia
Exclusion criteria
Date of most recent PSMA PET scan more than 2 weeks ago Known allergy or adverse reaction to Exenatide, other GLP-1 agonist or meta-Cresol Creatinine clearance less than 30mL/minute and/or dialysis dependent renal failure Type 1 diabetes Severe gastrointestinal disease Use of warfarin Past history of pancreatitis New York Heart Association Class IV dyspnoea Intercurrent severe depression Factors that would make it impractical to have radioactive urine Variables that in the opinion of a member of the research team preclude the opportunity for informed consent and/or adherence to study protocol by a potential participant.
Outcome results
None listed