- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03911310
[18F]PSMA-11 PET/CT Phase 3 Clinical Study (NGP3)
[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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
East Flanders
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Ghent, East Flanders, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PET/CT 1: [18F]PSMA-11, PET/CT 2: [68Ga]PSMA-11
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.
|
[18F]PSMA-11 PET/CT
[68Ga]PSMA-11 PET/CT
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ACTIVE_COMPARATOR: PET/CT 1: [68Ga]PSMA-11, PET/CT 2: [18F]PSMA-11
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.
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[18F]PSMA-11 PET/CT
[68Ga]PSMA-11 PET/CT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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).
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0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
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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
|
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).
|
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
|
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).
|
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
|
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).
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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
|
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.
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0 to 180 days post [18F]PSMA-11 and [68Ga]PSMA-11 administration
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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
|
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.
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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
|
This endpoint will be evaluated by determining a Cohen's kappa value
|
0 to 100 minutes post injection for both [18F]PSMA-11 and [68Ga]PSMA-11
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGO/2018/003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Novartis PharmaceuticalsCompletedRecurrence | Prostatic Neoplasms | Prostate CancerSpain, France, Switzerland, United States
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Central Hospital, Nancy, FranceGIE NANCYCLOTEP; Advanced Nuclear Medicine Ingredients (ANMI)Unknown
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Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH); Telix International...Active, not recruitingProstate AdenocarcinomaUnited States
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Wuhan Union Hospital, ChinaRecruitingProstate Cancer | PET/MR | PET/CTChina
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National Cancer Institute (NCI)Enrolling by invitationProstate Cancer | Metastatic Prostate Cancer | Cancer Of Prostate | Prostate Neoplasms | Prostatic CancerUnited States
-
University of AlbertaActive, not recruiting
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University Health Network, TorontoNot yet recruitingAdvanced Prostate CancerCanada