A prospective study to assess additional benefit of Fluorodeoxyglucose (FDG) PET scanning after staging with Prostate Specific Membrane Antigen (PSMA) PET for newly diagnosed high grade prostate cancer
- Conditions
- Prostate cancerCancer - Prostate
- Registration Number
- ACTRN12621001185853
- Lead Sponsor
- Metro North Hospital and Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 32
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of FDG PET and PSMA-PET/CT for determining the presence or absence of pelvic nodal or distant metastases. Diagnostic accuracy will be defined by comparing PET findings to a composite endpoint based on follow-up data (adapted from ProPSMA trial, Hofman et al. Lancet 395(10231):1208-1216).[ 12 months after registration]
- Secondary Outcome Measures
Name Time Method