None listed
Conditions
Brief summary
The purpose of this study is to compare two different types of PET-CT scans (Positron Emission Tomography - Computed Tomography) for imaging prostate cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have a confirmed diagnosis of prostate cancer or suspected prostate cancer recurrence, and your doctor believes that a PET scan would be helpful for treatment decisions. Study details All participants in this study will have two PET scans. One will be a routine standard-of-care scan (68Ga-PSMA), and the other will be a newer investigational scan (18F-PSMA). Before each scan, participants will be injected in the arm with a different tracer chemical. These tracer chemicals will localise to the prostate cancer. For one scan, this will happen 50 minutes before, and in the other it will happen 3 hours before. An optional subgroup will have additional scans (but no additional injections) on the day of one of these scans. The scans on this day will be one hour, two hours, and three hours after the injection. This will measure how the injected tracer moves through the body at different times. It is hoped this research will demonstrate the two tracers are equivalent, or the newer one is better. This may provide additional imaging options for patients with prostate cancer.
Interventions
This study aims to compare two PET radiotracers in primary and recurrent prostate cancer.
The protein PSMA (Prostate Specific Membrane Antigen) is commonly present in high levels in prostate cancer, and this study uses two radiotracers that specifically target PSMA to identify sites of prostate cancer (routinely-used 68Ga-PSMA-11 and the newer 18F-PSMA-1007).
All patients will have two PSMA PET-CT scans, performed within 4-7 days of each other. The scan order will be randomised but unblinded:
O
This study aims to compare two PET radiotracers in primary and recurrent prostate cancer. The protein PSMA (Prostate Specific Membrane Antigen) is commonly present in high levels in prostate cancer, and this study uses two radiotracers that specifically target PSMA to identify sites of prostate cancer (routinely-used 68Ga-PSMA-11 and the newer 18F-PSMA-1007). All patients will have two PSMA PET-CT scans, performed within 4-7 days of each other. The scan order will be randomised but unblinded: One 68Ga-PSMA-11 PET-CT scan, with tracer injected intravenously 50 minutes prior to scanning. This is a routine scan that will be reported as per standard of care. The dose of this scan will be 180-250MBq. One 18F-PSMA-1007 PET-CT scan, with tracer injected intravenously 3 hours prior to scanning. This scan is investigational, and will not be reported. The dose of this scan will be 180-360MBq An optional 'kinetics' subcohort of 40 patients who agree to participate will have additional PET-CT scans, at 1h, 2h, and 3h after injection with the 18F-PSMA tracer, in order to measure the kinetics of tracer localisation. No additional time or tracer injection is required, but patients will be exposed to a small amount of extra radiation from the ultra low dose CT scans involved with the extra scanning procedures. Patients will be followed up three months post scanning for subsequent treatment, and for histopathological validation of imaging if patients had subsequent lymph node dissection.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) be >= 18 years of age 2) have a confirmed diagnosis of prostate cancer from: a) a biopsy-confirmed diagnosis of prostate cancer; b) suspected recurrent prostate cancer after primary treatment; there is no study-specific PSA threshold value for biochemical recurrence, but rather the assessment of suspected recurrence is left to the referring Dr; 3) have a management question, for which a PSMA PET-CT scan is indicated and, 4) be willing to have two PET-CT scans on separate days.
Exclusion criteria
1) unable to provide written informed consent for the study and, 2) unable to lie flat for the scans
Outcome results
None listed