None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate whether FDG PET is helpful for clinicians treating men with newly diagnosed aggressive prostate cancer (according to tissue histology) and staged with PSMA PET. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with aggressive prostate cancer (high risk features) and have not had treatment to date, but you may be planning to undergo surgery, radiotherapy or other treatments. Study details: All participants enrolled in this trial will undergo a FDG PET/CT scan. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the PET scans will be determined according to follow-up information available up to 12 months after entering the study. The findings of the scans will be investigated for their ability to predict future cancer outcomes. Patient reported outcomes (PROs) as to how the scans and subsequent treatment affect enrolled participants will also be assessed.
Interventions
Participants will undergo usual work up prior to and after prostate cancer diagnosis. PSMA PET will be completed prior to registration. The intended initial management plan will be documented at time of registration (baseline) by the referring clinician.
18F-FDG PET imaging is expected to be completed within 21 days following registration. Researchers will be present at time of imaging commencement to register attendance (adherence). 18F-FDG PET imaging will be completed according to standard
Participants will undergo usual work up prior to and after prostate cancer diagnosis. PSMA PET will be completed prior to registration. The intended initial management plan will be documented at time of registration (baseline) by the referring clinician. 18F-FDG PET imaging is expected to be completed within 21 days following registration. Researchers will be present at time of imaging commencement to register attendance (adherence). 18F-FDG PET imaging will be completed according to standard protocol as practiced on a daily basis at the RBWH. Participants will present to the Herston Imaging Research Facility (HIRF) and an IV cannula will be placed before injection of a bolus of FDG tracer (4.25MBq/kg, minimum 90MBq, maximum 310MBq). The patient will rest for the standard uptake time (1 hour) post FDG injection. At the end of the uptake period the patient will be moved to the PET/CT scanner where scanning will commence. The PET/CT acquisition will last approximately 30 minutes. The findings will be recorded for study purposes and provided to the referring clinician who may modify patient management or seek additional information based on the result. An updated management plan according to clinician direction will be submitted based on all information up at the 1 month time-point.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men aged 18 years or older 2. Untreated, histologically confirmed prostate cancer 3. High risk disease according to clinical features, at least one of; - Serum PSA >20ng/ml - Biopsy Gleason Grade 4+4 or higher / Grade Group 4 or higher - cT3/4 according to digital rectal examination (DRE) and/or magnetic resonance imaging (MRI) 4. Negative, Localised or metastatic disease according to PSMA PET/CT 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 6. Adequate haematological, renal, hepatic and pulmonary functions 7. Written informed consent provided 8. Willingness and ability to comply with all study protocols
Exclusion criteria
1. prior treatment with radiotherapy or systemic therapies (e.g. androgen deprivation therapy, chemotherapy) for prostate cancer for longer than 21 days 2. history of other active malignancy within last 2 years (except non-melanoma skin cancer and superficial bladder cancer) 3. severe active co-morbidity or other barrier to completing study processes
Outcome results
None listed