PSMA-PET/CT for Prostate Cancer

Prostate Cancer Clinical Trial

— NGP1  

Official title:

PSMA-PET/CT for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558711
• Other study ID #: AGO/2017/006
• Secondary ID: 2017-003461-96
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2018
• Est. completion date: March 29, 2018

Study information

• Verified date: June 2018
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 29, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 18F-PSMA
18F-PET imaging

Locations

Country	Name	City	State
Belgium	university hospital, Ghent	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of administration - follow up of adverse events	Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.	Adverse events are followed up until 24 hours after PSMA administration.
Primary	Safety of administration - change in blood pressure	Changes in blood pressure (systolic and diastolic, expressed in mm Hg)	hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Primary	Safety of administration - change in temperature	Changes in temperature (expressed in °C)	hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Primary	Safety of administration - change in heart rate	Changes in heart rate (expressed in beats per min)	hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection
Primary	Safety of administration - erythrocytes	Changes in erythrocytes count in plasma (expressed in 10^6/µL)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - haemoglobin	Changes in haemoglobin concentration in plasma (expressed in g/dL)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - leukocytes	Changes in leukocytes count in plasma (expressed in 10^3/µL)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - thrombocytes	Changes in thrombocytes count in plasma (expressed in 10^3/µL)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - sodium	Changes in sodium concentration in serum(expressed in mmol/L)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - creatinine	Changes in creatinine concentration in serum (expressed in mg/dL)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - AST	Changes in AST concentration in serum (expressed in U/L)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - ALT	Changes in ALT concentration in serum (expressed in U/L)	before and 300 minutes after 18F-PSMA administration
Primary	Safety of administration - Alkaline phosphatase	Changes in alkaline phosphatase concentration in serum (expressed in U/L)	before and 300 minutes after 18F-PSMA administration
Primary	Biodistribution of 18F-PSMA	Follow up of 18F-PSMA distribution over time in blood, urine, and organs. 18F-PSMA	0 to 300 minutes after 18F-PSMA administration
Secondary	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).	0 to 300 minutes after 18F-PSMA administration
Secondary	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.	0 to 300 minutes after 18F-PSMA administration