18-Fluoride (18F) labelled Sodium Fluoride (NaF)) Positron Emission Tomography (PET)/Computer Tomography (CT); the impact on pre-operative staging of intermediate and high risk prostate cancer
Not Applicable
- Conditions
- Prostate CancerCancer - Prostate
- Registration Number
- ACTRN12614000877684
- Lead Sponsor
- Dr. Simon Harley
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigate the incremental management impact of staging with 18F labelled NaF PET/CT in patients with intermediate to high risk prostate cancer. This will be done by using an ‘assessment of impact’ proforma which denotes high, medium, low and no impact to a management regimen based on certain changes in management intent and modality of therapy.Surgeons will record the management plan and goals of treatment (cure/palliative) upon viewing of the BS. At this stage they will be blinded to the PET/CT. Upon documentation, the PET/CT will become available for viewing and the surgeon will be asked to record their management plan and goals of treatment with the information gathered from the PET/CT[At time of diagnosis]
- Secondary Outcome Measures
Name Time Method Compare the detection of bone metastases by 99m-Tc-MDP Bone Scintigraphy (BS) and 18F labelled NaF PET/CT in patients with intermediate and high risk prostate cancer[At time of diagnosis]