No registrations found.
ID
Source
Brief title
Health condition
Prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
To obtain preliminary data on variability in PSMA expression by comparing prostate uptake on standard clinical 68Ga-PSMA PET/CT with 68Ga-PSMA PET/CT performed 4 weeks later.
Secondary outcome
Dynamic imaging will be performed in order to get insight when the uptake in the prostate is visible
Background summary
Prostate cancer is the third most common cancer in Europe and is still the leading cancer among men in the Netherlands with over 13,000 men diagnosed each year. 68-Gallium Prostate Specific Membrane Antigen (68Ga-PSMA) is an emerging imaging agent that already has been widely proven as a highly effective agent for restaging PCa cells, but also holds enormous potential for initial staging and image guided surgery. During surgery, 68Ga-PSMA can potentially be used for the assessment of resection margins based on Cerenkov Light emission. The interval between initial staging and subsequent prostatectomy surgery, however, ranges from 4 to 6 weeks. Since little is known about the PSMA expression over time without intervention, a study on this is required. If PSMA expression is equal between both scans, the inclusion and dose determination for image guided surgery can be based on the clinical 68Ga-PSMA PET/CT scan. In order to validate this, two PET scans will be performed in a test-retest setting in primary prostate cancer patients. Dynamic imaging will be performed in order to get insight when uptake in the prostate is visible. Subsequently this will be used also to establish the ideal timing of surgery after injection.The objective of this study is to obtain preliminary data on variability in PSMA expression by comparing the tracer uptake on conventional clinical 68Ga-PSMA PET/CT with an additional 68Ga-PSMA PET/CT (4 weeks later) within primary prostate cancer patients. Dynamic imaging will be performed in 5 patients in order to get insight when uptake in the prostate is visible.
Study objective
We expect that the second measurement will be different from the first measurement by no more than 10%.
Study design
Not applicable
Inclusion criteria
Proven primary prostate carcinoma
- >18 years
- Good knowledge of Dutch language
- Written informed consent
- Underwent a pelvic MRI-scan
- Eligible for 68Ga-PSMA PET/CT
- Lesion bigger than 10mm on MRI, to minimize partial volume effects
Exclusion criteria
Contraindications for a PET/CT scan.
- Therapy scheduled between scans
- No PSMA expression in the primary tumor on the first PET scan, excluded for the second scan
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8263 |
| CCMO | NL64593.031.18 |
| OMON | NL-OMON46835 |