A Phase 1 interventional study of 18F-PSMA in Prostate Cancer, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Phase 1, Interventional, and Diagnostic
Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker PSA (prostate specific antigen) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated.
With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning or radiological CT or MRI cannot determine where the metastases are. Therefore, [18F]-Choline PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent of patients choline-PET does not localize tumor either, especially in small tumors and/or very low PSA values.
The PSMA PET is already routinely used in many European centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. This has been a very consistent finding in scientifically reported patient studies.
Most of these investigations have been performed with PSMA labeled with Gallium-68. The investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many advantages, including a higher production yield enabling more patients to be scanned. Also from a perspective of radioprotection and financial costs, Fluor-18 is a better choice. Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Most patients will be > 65 years old, an estimate may be more than 80%.
Diagnostic Test: 18F-PSMA
18F-PET imaging
Safety of administration - follow up of adverse events
Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.
Time frame: Adverse events are followed up until 24 hours after PSMA administration.
Safety of administration - change in blood pressure
Changes in blood pressure (systolic and diastolic, expressed in mm Hg)
Time frame: hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Safety of administration - change in temperature
Changes in temperature (expressed in °C)
Time frame: hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Safety of administration - change in heart rate
Changes in heart rate (expressed in beats per min)
Time frame: hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Safety of administration - erythrocytes
Changes in erythrocytes count in plasma (expressed in 10\^6/µL)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - haemoglobin
Changes in haemoglobin concentration in plasma (expressed in g/dL)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - leukocytes
Changes in leukocytes count in plasma (expressed in 10\^3/µL)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - thrombocytes
Changes in thrombocytes count in plasma (expressed in 10\^3/µL)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - sodium
Changes in sodium concentration in serum(expressed in mmol/L)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - creatinine
Changes in creatinine concentration in serum (expressed in mg/dL)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - AST
Changes in AST concentration in serum (expressed in U/L)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - ALT
Changes in ALT concentration in serum (expressed in U/L)
Time frame: before and 300 minutes after 18F-PSMA administration
Safety of administration - Alkaline phosphatase
Changes in alkaline phosphatase concentration in serum (expressed in U/L)
Time frame: before and 300 minutes after 18F-PSMA administration
Biodistribution of 18F-PSMA
Follow up of 18F-PSMA distribution over time in blood, urine, and organs. 18F-PSMA
Time frame: 0 to 300 minutes after 18F-PSMA administration
Establishment of critical organs
Based on the biodistribution of 18F-PSMA (primary outcome 14), it will be investigated which organs receive the highest radiation dose (expressed in mGy/MBq).
Time frame: 0 to 300 minutes after 18F-PSMA administration
Investigation of the stability of 18F-PSMA over time in plasma
The stability of 18F-PSMA will be assessed via measurement of the percentage defluorination of the compound. Free 18F will be separated from 18F-PSMA using solid-phase extraction, radioactivity (kBq/cc) of each fraction will be measured.
Time frame: 0 to 300 minutes after 18F-PSMA administration
Plan to share: No
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University Hospital, Ghent