None listed
Conditions
Brief summary
This clinical trial will investigate a new type of scan called 18F-DCPYL-PET which provides whole body images of prostate cancer spread, in patients that have had a negative biopsy. We propose that in men with a high clinical index of suspicion for prostate cancer, 18F-DCPYL-PET may be a successful tool to aid early diagnosis of prostate cancer.
Interventions
Substance/Device intervention: 18F - DCPyL - Positron Emission Tomography/Computed Tomography (PET/CT)
PET/CT Scan: Uses small amounts of radioactive materials called radiotracers, 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. A certified PET radiologist will perform the imaging. The PET/CT scan will be performed once only and l
Substance/Device intervention: 18F - DCPyL - Positron Emission Tomography/Computed Tomography (PET/CT) PET/CT Scan: Uses small amounts of radioactive materials called radiotracers, 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. A certified PET radiologist will perform the imaging. The PET/CT scan will be performed once only and last approximately 120 minutes. 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. Participants will be enrolled via strict inclusion/exclusion criteria and will be thoroughly examined prior to imaging to ensure there is no additional risks to participants. During imaging, a radiologist, a nuclear medicine technician and/or research nurse will be present from PSMA does through to end of imaging session to ensure participants are safely monitored.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
High clinical suspicion for prostate cancer (within 12mo) based on the following criteria: • positive mpMRI suggesting presence of prostate cancer, but who have had a negative prostate biopsy. • Prostate-Specific Antigen (PSA) >10 or • PSA density > 0.15 or • Palpable abnormality on Digital Rectal Exam (DRE) or • MRI lesion PIRADS greater than or equal to 4 and size >5mm AND men with greater than or equal to 1 negative prostate biopsy, undertaken via any of the following techniques: - cognitive fusion transrectal - cognitive fusion transperineal - software fusion transperineal • Age 18 years and above • Patient has provided written informed consent for participation in this trial • In the opinion of investigator, willing and able to comply with required study procedures
Exclusion criteria
Patients who have developed interval contra-indication to have mpMRI prostate: • MRI incompatible implants or metal fragments • claustrophobia • unable to have intravenous gadolinium • unable to fit in the MRI due to BMI Significant inter-current morbidity that, in the judgment of the investigator, would limit compliance with study protocols
Outcome results
None listed