Prostate CancerPhase 1NGP1NCT03558711
PSMA-PET/CT for Prostate Cancer
A Phase 1 study testing 18F-PSMA in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-PSMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jan 2018to 29 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- 18F-PSMA
- Keywords
- prostate cancer, biochemical recurrence, 18F-PET imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMADiagnostic test
18F-PET imaging
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Diagnostic Test: 18F-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administration - follow up of adverse events
Follow up of treatment-related adverse events according to CTCAE v4.0 criteria.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - haemoglobin
Changes in haemoglobin concentration in plasma (expressed in g/dL)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - leukocytes
Changes in leukocytes count in plasma (expressed in 10^3/µL)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - thrombocytes
Changes in thrombocytes count in plasma (expressed in 10^3/µL)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - sodium
Changes in sodium concentration in serum(expressed in mmol/L)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - creatinine
Changes in creatinine concentration in serum (expressed in mg/dL)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - AST
Changes in AST concentration in serum (expressed in U/L)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - ALT
Changes in ALT concentration in serum (expressed in U/L)
Measured: before and 300 minutes after 18F-PSMA administration
Safety of administration - Alkaline phosphatase
Changes in alkaline phosphatase concentration in serum (expressed in U/L)
Measured: 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
Measured: 0 to 300 minutes after 18F-PSMA administration
Secondary outcomes (2)
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).
Measured: 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.
Measured: 0 to 300 minutes after 18F-PSMA administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start4 Jan 2018
- Primary completion27 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intravenous \[18F\]-PSMA-11
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558711
- Sponsor's protocol ID
- AGO/2017/006
- Other IDs
- 2017-003461-96, 2017
- Acronym
- NGP1
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET/CT for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03558711
- Acronym / sponsor ID
- NGP1 / AGO/2017/006
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, biochemical recurrence, 18F-PET imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intravenous [18F]-PSMA-11
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Diagnostic Test: 18F-PSMA |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-PSMA18F-PET imaging | Diagnostic test | study group |
Primary outcome
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.
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)
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)
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)
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)
Safety of administration - haemoglobin
Time frame: before and 300 minutes after 18F-PSMA administration
Changes in haemoglobin concentration in plasma (expressed in g/dL)
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)
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)
Safety of administration - sodium
Time frame: before and 300 minutes after 18F-PSMA administration
Changes in sodium concentration in serum(expressed in mmol/L)
Safety of administration - creatinine
Time frame: before and 300 minutes after 18F-PSMA administration
Changes in creatinine concentration in serum (expressed in mg/dL)
Safety of administration - AST
Time frame: before and 300 minutes after 18F-PSMA administration
Changes in AST concentration in serum (expressed in U/L)
Safety of administration - ALT
Time frame: before and 300 minutes after 18F-PSMA administration
Changes in ALT concentration in serum (expressed in U/L)
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)
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
2 secondary outcomes
Establishment of critical organs
Time frame: 0 to 300 minutes after 18F-PSMA administration
Investigation of the stability of 18F-PSMA over time in plasma
Time frame: 0 to 300 minutes after 18F-PSMA administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-PSMA in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administration - follow up of adverse events (time frame: Adverse events are followed up until 24 hours after PSMA administration.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.