None listed
Conditions
Brief summary
The purpose of this study is to compare a new imaging technique (called 18F-DCPYL-PET/CT) to standard imaging. Who is it for? You may be eligible for this study if you are a male aged 18 or older and are due for imaging to see if you have prostate cancer. Study details All participants in this study will have two scans. One is a multi-parametric magnetic resonance imaging (mpMRI) scan, which is the standard imaging technique used. The other scan is a Positron Emission Tomography (PET) scan, which will be combined with a technique called computed tomography (CT). The PET scan required injection of a chemical called 18F-DCPYL, using a needle in the arm. Researchers will use the results of these scans to see if the 18F-DCPYL scan is as useful as the mpMRI. As part of the study, participants will consent to access medical records, in addition to the scans. It is hoped this research will demonstrate the 18F-DCPYL scan can improve our ability to detect prostate cancer.
Interventions
Substance/Device intervention: 18F-DCPyL-PET/CT
Positron Emission Tomography (PET)Scan: Uses small amounts of radioactive materials calledradiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests.
18FDCPyL is the PET Radiotracer, injected into the arm or hand vein intravenously. The small amount of radioactive substance w
Substance/Device intervention: 18F-DCPyL-PET/CT Positron Emission Tomography (PET)Scan: Uses small amounts of radioactive materials calledradiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests. 18FDCPyL is the PET Radiotracer, injected into the arm or hand vein intravenously. The small amount of radioactive substance will allow the PET to detect radioactivity. Patients will be administered a single, intravenous bolus dose of 18F-DCFPyL PSMA. 250MBq 18F-DCFPyL (acceptable: 200-350MBq depending on patient weight and activity provided on day of scan) (calculated according to body weight and available activity) - the administered activity of 18F-DCFPyL PSMA is approximately 3MBq per kilogram bodyweight up to 350 maximum dose. Scanner: Patients will be imaged on a GE Discovery 710 PET/CT (General Electric Medical Systems, Milwaukee, WI) combining a 64 slice multidetector CT scanner with a dedicated, full ring PET scanner with lutetium-based crystals. Injection of radiotracer and the imaging will be performed by a qualified radiologist/nuclear medicine PET-CT technician. Both mpMRI and the PET//CTs can will be performed once, post participant screening & consent and on the same day. The PET/CT scan will take place 2 hours post injection of the 18F-DCFPyL PSMA for all patients. The duration of the PET/CT scan will take ~19 minutes for patients <90kg OR ~22 minutes for patients >90kg.
Sponsors
Mr Lih-Ming Wong
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men (greater to or equal than 18 years) with an elevated PSA who are suitable for an eligible MBS mpMRI prostate (MBS items 63541 and 63542 NK) 2. For MBS items 63541 and 63542 (NK) the patient must be suspected of having prostate cancer based on (*): a) a digital rectal examination (DRE) which is suspicious for prostate cancer; or b) in a person aged less than 70 years, at least two prostate specific antigen (PSA) tests performed within an interval of 1- 3 months are greater than 3.0 ng/ml, and the free/total PSA ratio is less than 25% or the repeat PSA exceeds 5.5 ng/ml; or c) in a person aged less than 70 years, whose risk of developing prostate cancer based on family history is at least double the average risk, at least two PSA tests performed within an interval of 1-3 months are greater than 2.0 ng/ml, and the free/total PSA ratio is less than 25%; or d) in a person aged 70 years or older, at least two PSA tests performed within an interval of 1-3 months are greater than 5.5ng/ml and the free/total PSA ratio is less than 25%. NB: Relevant family history is a first degree relative with prostate cancer or suspected of carrying a BRCA 1, BRCA 2 mutation. (*)http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Factsheet-MRIProstate 3. Patient has provided written informed consent for participation in trial 4. In the opinion of the investigator, willing and able to comply with required study procedures
Exclusion criteria
1. Known diagnosis of prostate cancer. 2. Previous prostate biopsy within 3 years of recruitment. A transurethral resection of the prostate performed for primary purpose of alleviating lower urinary tract symptoms is considered acceptable. 3. Previous mpMRI prostate within 3 years of recruitment. 4. History of other active malignancy within the last 3 years, with the exception of nonmelanoma skin cancer or melanoma in-situ. 5. Any absolute contra-indication to 3T mpMRI prostate, or previous history of total hip joint replacement. 6. Significant intercurrent morbidity that, in the judgement of the investigator, would limit compliance with study protocols
Outcome results
None listed