None listed
Conditions
Brief summary
This study will investigate the management impact of staging with a diagnostic scan known as 18-F Sodium Fluoride PET/CT compared to bone scintigraphy in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged at least 18 years with newly diagnosed, untreated, biopsy confirmed, intermediate to high risk prostate cancer. Study details: All participants in this study will undergo two different diagnostic tests. The first test is called 18-F Sodium Fluoride Positron Emission Tomography (PET)/Computed Tomography (CT), and this involves the injection of a small amount of radioactive tracer into your veins. You body is then scanned to look for areas of tracer-uptake which may suggest cancer in your bones. The second test is called bone scintigraphy, and this involves a different radioactive tracer. Surgeons will first view the bone scintigraphy and use this to record a management plan and treatment goals. They will then view the 18-F Sodium Fluoride PET/CT and record a separate management plan. It is suggested that 18-F Sodium Fluoride PET/CT can pick up prostate cancer that has spread to the bone better than Bone Scintigraphy (BS). We wish to assess whether having access to 18-F Sodium Fluoride PET/CT actually changes the surgeons intended management of men with intermediate to high risk prostate cancer, and whether the detection of bone metastases (cancer spread to bone) is different between tests.
Interventions
All men will undergo both the NaF PET/CT as well as the Bone Scintigraphy (BS) only once (at the time of prostate cancer diagnosis). These will be done within a three day period and most likely on two consecutive days; both scans cannot be done on the same day.
The PET/CT uses the radio-active marker 18F NaF which is injected intravenously. The patient will then be scanned, roughly 45-90 minutes later. This scan picks up abnormalities within bone, but is more sensitive than the Bone Scintigraph
All men will undergo both the NaF PET/CT as well as the Bone Scintigraphy (BS) only once (at the time of prostate cancer diagnosis). These will be done within a three day period and most likely on two consecutive days; both scans cannot be done on the same day. The PET/CT uses the radio-active marker 18F NaF which is injected intravenously. The patient will then be scanned, roughly 45-90 minutes later. This scan picks up abnormalities within bone, but is more sensitive than the Bone Scintigraphy. Within the next two days, the patient will then undergo the Bone Scintigraphy.
Sponsors
Dr. Simon Harley
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 100 Years
Healthy volunteers
No
Inclusion criteria
All men aged 18 years and above with newly diagnosed, untreated biopsy confirmed prostate cancer with intermediate to high risk prostate cancer as defined by D’Amico Classification (Gleason score equal to/greater than 7 , PSA greater/equal to 10)
Exclusion criteria
Men with a second (non-prostate) cancer Men who have had previous neo-adjuvant hormonal or radiation therapy for prostate cancer. Men unable to give informed consent
Outcome results
None listed