Prostate CancerPhase 3NGP3NCT03911310
[18F]PSMA-11 PET/CT Phase 3 Clinical Study
A Phase 3 study testing [18F]PSMA-11 and [68Ga]PSMA-11 in people with Prostate Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [18F]PSMA-11 and [68Ga]PSMA-11
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2019to 20 Sep 2020
- Phase
- Phase 3
- 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 18 years and older
- 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 previous treatment, or at primary diagnosis and staging.
Who cannot join
- Age < 18 years
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans
- History of anaphylactic shock after administration of Visipaque CT contrast
- Serum creatinine concentration > 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [18F]PSMA-11 PET/CT for Prostate Cancer - Phase 3 Clinical Study
Prostate cancer (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. 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.
Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.
- Conditions
- Prostate Cancer
- Being tested
- [18F]PSMA-11, [68Ga]PSMA-11
- Keywords
- prostate cancer, biochemical recurrence, 18F-PSMA 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]PSMA-11Diagnostic test
[18F]PSMA-11 PET/CT
[68Ga]PSMA-11Diagnostic test
[68Ga]PSMA-11 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11 | Experimental | Patients in this arm will first receive the experimental radiotracer [18F]PSMA-11 PET/CT followed by the [68Ga]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks. Receives: Diagnostic Test: [18F]PSMA-11; Diagnostic Test: [68Ga]PSMA-11 |
| PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11 | Active comparator | Patients in this arm will first receive the experimental radiotracer [68Ga]PSMA-11 PET/CT followed by the [18F]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks. Receives: Diagnostic Test: [18F]PSMA-11; Diagnostic Test: [68Ga]PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
The non-inferiority of [18F]PSMA-11 will be investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of [18F]PSMA-11 compared to [68Ga]PSMA-11 with matched pairs. Non-inferiority will be concluded if the lower limit of this CI is larger than 0.10 (non-inferiority limit).
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Secondary outcomes (7)
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
Superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans will be statistically assessed by applying a McNemar's test on the proportions of positive PET scans in each group. Hereby, superiority is defined as a difference of minimum 10% in the proportions of positive PET scans ([18F]PSMA-11 > [68Ga]PSMA-11).
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans.
The McNemar-Bowker test of symmetry of k X k contingency tables will be applied to investigate differences between [18F]PSMA-11 and [68Ga]PSMA-11 scans. Hereby, the superiority is defined as a difference of minimum 10% ([18F]PSMA-11 > [68Ga]PSMA-11).
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions.
The McNemar-Bowker test of symmetry of k X k contingency tables will be applied to investigate differences between [18F]PSMA-11 and [68Ga]PSMA-11 scans. Hereby, the superiority is defined as a difference of minimum 10% ([18F]PSMA-11 > [68Ga]PSMA-11).
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA
This endpoint will be examined in the total group of patients, as well as in a subgroup of patients with a specific disease stage including primary diagnosis, castrate sensitive biochemical recurrence, and castrate resistant biochemical recurrence. Additionally, within these subgroups, a further subdivision can be made on the basis of a specific location of the suspected lesions, PSA values, PSA doubling times and metastatic disease burden).
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11
This endpoint will be evaluated in a descriptive way, more specifically by a description of the number of positive scans (and/or positive lesions) that can be confirmed via an anatomopathological diagnosis, changes in PSA concentration or via MRI, and by comparison of these numbers between [18F]PSMA-11 and [68Ga]PSMA-11.
Measured: 0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration
Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria
Adverse events will be reported and scored (CTCAE 4.0 criteria) between the first dose administration of trial medication and the last trial related activity. From the time of radiotracer injection till completion of the PET/CT scan (for both [18F]PSMA-11 and [68Ga]PSMA-11), the site staff will visually observe and actively ask the patient whether or not he has observed any adverse effects. Although [18F]PSMA-11 is totally eliminated from the body within 9 hours post injection (= 10 x half-life of 47 ± 5 minutes), AE's occurring up to 24h after the second PET/CT scan will also be handled as such if spontaneously reported by the patient to the investigator.
Measured: 0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration
Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans
This endpoint will be evaluated by determining a Cohen's kappa value
Measured: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Apr 2019
- Primary completion20 Mar 2020
- Study completion20 Sep 2020
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.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The trial encompasses a double-blind randomized cross-over design whereby each patient will be subjected to a \[18F\]PSMA-11 scan and a \[68Ga\]PSMA-11 scan, with an interscan period of four days to maximum three weeks. Half of the patients will be first scanned with \[18F\]PSMA-11 and subsequently (maximum three weeks later) with \[68Ga\]PSMA-11. The scan order in the remaining group of patients will be reversed. Randomization of patients to one of these groups will be performed using a block randomization design with block sizes of six.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piet Ost, Prof., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911310
- Sponsor's protocol ID
- AGO/2018/003
- Acronym
- NGP3
- Status last verified
- Jan 2021
- First submitted
- 8 Apr 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]PSMA-11 PET/CT for Prostate Cancer - Phase 3 Clinical Study
- ClinicalTrials.gov ID
- NCT03911310
- Acronym / sponsor ID
- NGP3 / AGO/2018/003
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, biochemical recurrence, 18F-PSMA PET imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 11 Apr 2019 (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 (PCa) is the most frequently occurring male cancer in Belgium. After treatment with surgery and/or radiotherapy, almost half of the patients suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker Prostate Specific Antigen (PSA) within the first few years after primary treatment. However, for salvage therapy to be successful, precise localization of metastases is necessary to determine the most appropriate treatment. 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.
Recently, prostate specific membrane antigen (PSMA) has gained interest for PCa-specific imaging. Due to overexpression of PSMA in both primary and metastatic PCa, radiotracers targeting this protein have shown an increased selectivity and sensitivity compared to conventional imaging. The main objective of this phase 3 trial is to determine the position of [18F]PSMA-11 PET/CT within the field of available radiotracers for diagnosis of prostate cancer. For this, the diagnostic performances of [18F]PSMA-11 will be compared to those of the current state-of-the-art radiotracer [68Ga]PSMA-11.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The trial encompasses a double-blind randomized cross-over design whereby each patient will be subjected to a [18F]PSMA-11 scan and a [68Ga]PSMA-11 scan, with an interscan period of four days to maximum three weeks. Half of the patients will be first scanned with [18F]PSMA-11 and subsequently (maximum three weeks later) with [68Ga]PSMA-11. The scan order in the remaining group of patients will be reversed. Randomization of patients to one of these groups will be performed using a block randomization design with block sizes of six.
| Arm | Type | Receives |
|---|---|---|
| PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11 | Experimental | Diagnostic Test: [18F]PSMA-11, Diagnostic Test: [68Ga]PSMA-11Patients in this arm will first receive the experimental radiotracer [18F]PSMA-11 PET/CT followed by the [68Ga]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks. |
| PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11 | Active comparator | Diagnostic Test: [18F]PSMA-11, Diagnostic Test: [68Ga]PSMA-11Patients in this arm will first receive the experimental radiotracer [68Ga]PSMA-11 PET/CT followed by the [18F]PSMA-11 PET/CT after at least 4 days and maximum 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- 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 previous treatment, or at primary diagnosis and staging.
Key exclusion criteria (5 listed)
- Age < 18 years
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans
- History of anaphylactic shock after administration of Visipaque CT contrast
- Serum creatinine concentration > 2.0 mg/dl and/or estimated glomerular filtration rate < 60 ml/min.
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]PSMA-11[18F]PSMA-11 PET/CT | Diagnostic test | PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11, PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11 |
| [68Ga]PSMA-11[68Ga]PSMA-11 PET/CT | Diagnostic test | PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11, PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11 |
Primary outcome
Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
The non-inferiority of [18F]PSMA-11 will be investigated based on a Tango's score two-sided 95% confidence interval (CI) for a difference of proportions of positive scans of [18F]PSMA-11 compared to [68Ga]PSMA-11 with matched pairs. Non-inferiority will be concluded if the lower limit of this CI is larger than 0.10 (non-inferiority limit).
7 secondary outcomes
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion.
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the total number of suspected prostate cancer lesions in corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) scans.
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the superiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the scoring of corresponding ([68Ga]PSMA-11 vs [18F]PSMA-11) suspected lesions.
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Descriptive evaluation of [18F]PSMA-11 compared to [68Ga]PSMA
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
Evaluation of the diagnostic specificity of [18F]PSMA-11 compared to [68Ga]PSMA-11
Time frame: 0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration
Evaluation of the safety of [18F]PSMA-11 administration: CTCAE 4.0 criteria
Time frame: 0 to 24 h post [18F]PSMA-11 and [68Ga]PSMA-11 administration
Assessment of the interobserver variability with regard to the evaluation of the [18F]PSMA-11 and [68Ga]PSMA-11 PET scans
Time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
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 22 Jan 2021.
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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.
Piet Ost, Prof. principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]PSMA-11 and [68Ga]PSMA-11 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 5 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 22 Jan 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of the non-inferiority of [18F]PSMA-11 compared to [68Ga]PSMA-11 with respect to the number of positive PET scans. Hereby, a positive PET scan is defined as a scan showing at least one suspected lesion. (time frame: 0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11). 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 22 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.