Clinical trial NCT03558711: PSMA-PET/CT for Prostate Cancer
Official title: PSMA-PET/CT for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate cancer
biochemical recurrence
18F-PET imaging
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intravenous \[18F\]-PSMA-11
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after curative treatment (prostatectomy with or without lymphadenectomy or radiotherapy), or at primary diagnosis and staging.

Exclusion Criteria:

* Age \< 40 or \> 70 years in phase-1; upper age limit is not applicable for the phase-2 trial.

Most patients will be \> 65 years old, an estimate may be more than 80%.

* Physically or mentally unfit to perform the sequential procedures
* Refusal of patient to be informed about accidental findings on scans.

Primary outcomes:
measure: Safety of administration - follow up of adverse events
timeFrame: Adverse events are followed up until 24 hours after PSMA administration.
measure: Safety of administration - change in blood pressure
timeFrame: hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
measure: Safety of administration - change in temperature
timeFrame: hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
measure: Safety of administration - change in heart rate
timeFrame: hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
measure: Safety of administration - erythrocytes
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - haemoglobin
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - leukocytes
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - thrombocytes
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - sodium
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - creatinine
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - AST
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - ALT
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Safety of administration - Alkaline phosphatase
timeFrame: before and 300 minutes after 18F-PSMA administration
measure: Biodistribution of 18F-PSMA
timeFrame: 0 to 300 minutes after 18F-PSMA administration
Secondary outcomes:
measure: Establishment of critical organs
timeFrame: 0 to 300 minutes after 18F-PSMA administration
measure: Investigation of the stability of 18F-PSMA over time in plasma
timeFrame: 0 to 300 minutes after 18F-PSMA administration
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: university hospital, Ghent
Study officials:
References: