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Completed

NCT Number: NCT03558711

PSMA-PET/CT for Prostate Cancer

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

university hospital, Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-PSMA

Diagnostic Test

18F-PET imaging

Primary outcomes

  1. Safety of administration - follow up of adverse events

    Time frame: Adverse events are followed up until 24 hours after PSMA administration.

    Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.

  2. Safety of administration - change in blood pressure

    Time frame: hourly checking of blood pressure from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection

    Changes in blood pressure (systolic and diastolic, expressed in mm Hg)

  3. Safety of administration - change in temperature

    Time frame: hourly checking of temperature from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection

    Changes in temperature (expressed in °C)

  4. Safety of administration - change in heart rate

    Time frame: hourly checking of heart rate from timepoint of 18F-PSMA-11 injection up to 5 hours post 18F-PSMA injection

    Changes in heart rate (expressed in beats per min)

  5. Safety of administration - erythrocytes

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in erythrocytes count in plasma (expressed in 10^6/µL)

  6. Safety of administration - haemoglobin

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in haemoglobin concentration in plasma (expressed in g/dL)

  7. Safety of administration - leukocytes

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in leukocytes count in plasma (expressed in 10^3/µL)

  8. Safety of administration - thrombocytes

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in thrombocytes count in plasma (expressed in 10^3/µL)

  9. Safety of administration - sodium

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in sodium concentration in serum(expressed in mmol/L)

  10. Safety of administration - creatinine

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in creatinine concentration in serum (expressed in mg/dL)

  11. Safety of administration - AST

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in AST concentration in serum (expressed in U/L)

  12. Safety of administration - ALT

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in ALT concentration in serum (expressed in U/L)

  13. Safety of administration - Alkaline phosphatase

    Time frame: before and 300 minutes after 18F-PSMA administration

    Changes in alkaline phosphatase concentration in serum (expressed in U/L)

  14. Biodistribution of 18F-PSMA

    Time frame: 0 to 300 minutes after 18F-PSMA administration

    Follow up of 18F-PSMA distribution over time in blood, urine, and organs. 18F-PSMA

Secondary outcomes

  1. Establishment of critical organs

    Time frame: 0 to 300 minutes after 18F-PSMA administration

    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).

  2. Investigation of the stability of 18F-PSMA over time in plasma

    Time frame: 0 to 300 minutes after 18F-PSMA administration

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: NGP1

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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