Phase 0 Trial of Gallium-68 tris-hydroxypyridinone prostate specific membrane antigen (Ga-68 THP-PSMA) positron emission tomography (PET) scanning for prostate cancer
Phase 1
Completed
- Conditions
- Cancer - Prostateprostate cancer
- Registration Number
- ACTRN12615001324505
- Lead Sponsor
- Peter MacCallum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 14
Inclusion Criteria
1.Age 18 – 80 years
2.Proven adenocarcinoma of the prostate gland.
3.All patients have to be suitable for surgical treatment as part of their normal management
4.Able to comply with treatment plans, scheduled visits, all study PET imaging and follow-up
Exclusion Criteria
1.Any prior treatment for the prostate gland tumours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess Ga-68 THP-PSMA safety[- vital signs following THP-PSMA injection<br>- blood tests (full blood count, urea and electrolytes, liver function tests) 24 hours following injection<br>- telephone follow-up at 24 hours];To assess the biodistribution of Ga-68 THP-PSMA [Analysis of PET images throughout 3 hour scan period:: description of standardised uptake value (SUV) in normal tissues];To calculate radiation dosimetry of Ga-68 THP-PSMA [Analysis of PET images throughout the 3 hour scan period: radiation dosimetry expressed as microSv/MBq of administered activity]
- Secondary Outcome Measures
Name Time Method To assess optimal imaging time for Ga-68 THP-PSMA using assessment of dynamic PET scans[At time of scanning<br>- qualitative assessment by visual analysis of the images at different time points];Determine by immunohistochemistry expression of PSMA relationship to Ga-68 THP-PSMA uptake as determined by PET scanning[Visual analysis of PSMA uptake within prostate gland compared to PSMA immunohistochemistry from surgical specimen following prostatectomy]