Imaging of the prostate tumors using PET/CT and PET/MRI with the ligand of the prostatic specific membrane antigene 68Ga-PSMA-11
Phase 1
- Conditions
- prostatic carcinoma higly suspected or its staging or restagingTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2017-004128-32-CZ
- Lead Sponsor
- Fakultní nemocnice Plzen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
prostatic carcinoma higly suspected or its staging or restaging in male older than 18, WHO performance status 1 or 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Exclusion Criteria
WHO performance status 3 or 4, renal mpairment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Secondary Objective: to validate imaging protocol;Primary end point(s): relation of the accumulation level with biological behavior of the tumorosu tissue, degree of the tumorou spread within an organism and serum levels of prostatic specific antigene;Timepoint(s) of evaluation of this end point: early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150
- Secondary Outcome Measures
Name Time Method Secondary end point(s): validation of the imaging protocol;Timepoint(s) of evaluation of this end point: early evaluation after 15 - 20 examinations, than intermediate after 50 , 100 and 150