PSMA-PET/CT for Prostate Cancer
Phase 1
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT03558711
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Inclusion Criteria:<br><br> - Patients diagnosed with prostate cancer, either in the setting of diagnosis of<br> biochemical recurrence after curative treatment (prostatectomy with or without<br> lymphadenectomy or radiotherapy), or at primary diagnosis and staging.<br><br>Exclusion Criteria:<br><br> - Age < 40 or > 70 years in phase-1; upper age limit is not applicable for the phase-2<br> trial.<br><br>Most patients will be > 65 years old, an estimate may be more than 80%.<br><br> - Physically or mentally unfit to perform the sequential procedures<br><br> - Refusal of patient to be informed about accidental findings on scans.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of administration - follow up of adverse events;Safety of administration - change in blood pressure;Safety of administration - change in temperature;Safety of administration - change in heart rate;Safety of administration - erythrocytes;Safety of administration - haemoglobin;Safety of administration - leukocytes;Safety of administration - thrombocytes;Safety of administration - sodium;Safety of administration - creatinine;Safety of administration - AST;Safety of administration - ALT;Safety of administration - Alkaline phosphatase;Biodistribution of 18F-PSMA
- Secondary Outcome Measures
Name Time Method Establishment of critical organs;Investigation of the stability of 18F-PSMA over time in plasma