Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for localizing primary prostate cancer prior to radical prostatectomy
- Conditions
- prostate cancer, prostaatkanker
- Registration Number
- NL-OMON29500
- Lead Sponsor
- niversiy Medical center Groningen (UMCG)
- Brief Summary
not applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
•Male aged 18 years or older
•Ability to provide signed informed consent and willingness to comply with protocol requirements.
Exclusion Criteria
•Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
•Have a contraindication for mpMRI. (part A and B)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the ideal timing of performing the WB 68Ga-PSMA PET after administration of the radiotracer and to determine the optimal (quantitative) pharmacokinetic model for describing 68Ga-PSMA uptake (Part A).<br /><br>To study test-retest characteristics of 68Ga PSMA PET (Part B). <br>
- Secondary Outcome Measures
Name Time Method - To determine whether it is feasible to exactly identify and localize the tumour within the prostate with PSMA PET/CT(Part A and B).<br /><br>- Comparison of 68Ga-PSMA PET (study visit) versus mpMRI (standard of care) regarding to tumour localization within the prostate. <br>