NCT03558711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 prostate-cancer

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

February 1, 2018

Last Update Submit

September 5, 2024

Conditions

Prostate Cancer

Keywords

prostate cancerbiochemical recurrence18F-PET imaging

Outcome Measures

Primary Outcomes (14)

  • 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.

  • 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

  • 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

  • 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

  • Safety of administration - erythrocytes

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - haemoglobin

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - leukocytes

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - thrombocytes

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - sodium

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - creatinine

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - AST

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - ALT

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

    before and 300 minutes after 18F-PSMA administration

  • Safety of administration - Alkaline phosphatase

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

    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

    0 to 300 minutes after 18F-PSMA administration

Secondary Outcomes (2)

  • Establishment of critical organs

    0 to 300 minutes after 18F-PSMA administration

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

    0 to 300 minutes after 18F-PSMA administration

Study Arms (1)

study group

EXPERIMENTAL
Diagnostic Test: 18F-PSMA

Interventions

18F-PSMADIAGNOSTIC_TEST

18F-PET imaging

study group

Eligibility Criteria

Age40 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale with prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university hospital, Ghent

Ghent, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: intravenous \[18F\]-PSMA-11
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

June 15, 2018

Study Start

January 4, 2018

Primary Completion

March 27, 2018

Study Completion

March 29, 2018

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)