- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573011
PSMA PET/CT for Prostate Cancer (NGP2)
PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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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
- Patients with heart failure if ejection fraction < 45% (phase 2 trial)
- History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
To define the optimal [18F]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg. Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm. As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference. |
18F-PET imaging
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Experimental: 4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
Concerning the dose of [18F]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the [18F]PSMA-11 scan.
All other study parameters and procedures are identical to those in the other study arm
|
18F-PET imaging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of effective targeting of prostate cancer and eventual metastases
Time Frame: 0 to 3.5 hours post radiotracer injection
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Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases
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0 to 3.5 hours post radiotracer injection
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Determination of the optimal scan protocol: define optimal time of scanning
Time Frame: 0 to 3.5 hours post radiotracer injection
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Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale - higher score represents a higher intensity lesion), the optimal time (60 min or 180 min post radiotracer injection) will be defined
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0 to 3.5 hours post radiotracer injection
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Determination of the optimal scan protocol: define optimal scan duration
Time Frame: 0 to 3.5 hours post radiotracer injection
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Based on the quality of the images and feasibility of tumor targetting (4 point '0-3' scoring scale, higher score represents a higher intensity lesion), the optimal scan duration (1.5 minutes/bed position or 3.0 minutes/bed position) will be defined
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0 to 3.5 hours post radiotracer injection
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Determination of the optimal scan protocol: define optimal dose
Time Frame: 0 to 3.5 hours post radiotracer injection
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Based on the overall image quality (7 point '1-7' scoring scale for image blurriness, higher score represents a higher quality image), the optimal dose of [18F]PSMA-11 (2.0 or 4.0 MBq/kg) will be defined
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0 to 3.5 hours post radiotracer injection
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Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol
Time Frame: 0 to 1.5 hours post radiotracer injection
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Based on the degree that the radiotracer uptake in the bladder and in the ureters is disruptive for the interpretation of the scan (visual interpretation by nuclearist using a 7 point '1-7' scoring scale, higher score equals a more pronounced disturbance), the added value of furosemide, as part of the standard scanprotocol, will be defined
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0 to 1.5 hours post radiotracer injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans
Time Frame: 0 - 60 days post [18F]PSMA-11 administration
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The inter-observer difference for analysing the [18F]PSMA-11 PET images will be investigated between at least two nuclear physicians.
Results will be expressed as a cohen's kappa
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0 - 60 days post [18F]PSMA-11 administration
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Evaluation of the diagnostic specificity of [18F]PSMA-11
Time Frame: 0 - 60 days post [18F]PSMA-11 administration
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Following the [18F]PSMA PET/CT scans in the phase 2 trial, the treating physician will continue the follow-up and treatment of the patient. Hereby, depending of the selected conventional treatment or procedure, the following data will be also collected (if available within 60 days following the day of the [18F]PSMA scan) to investigate the diagnostic specificity of [18F]PSMA-11:
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0 - 60 days post [18F]PSMA-11 administration
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Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy
Time Frame: Pre [18F]PSMA-11 PET management plan: between the date the patient signed the informed consent form and the date of the [18F]PSMA-11 scan. Post [18F]PSMA-11 PET management plan: 0 - 60 days post [18F]PSMA-11 administration
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The treating physician must fill in a questionnaire concerning the patients 'pre [18F]PSMA-11 PET' management plan.
After the scan, the physician must fill in a second part of the questionnaire concerning how the [18F]PSMA-11 scan would influence the patient's treatment plan.
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Pre [18F]PSMA-11 PET management plan: between the date the patient signed the informed consent form and the date of the [18F]PSMA-11 scan. Post [18F]PSMA-11 PET management plan: 0 - 60 days post [18F]PSMA-11 administration
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Collaborators and Investigators
Sponsor
Publications and helpful links
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/2017/006 phase 2 trial
- 2017-003461-96 (EudraCT Number)
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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-
Wuhan Union Hospital, ChinaRecruitingProstate Cancer | PET/MR | PET/CTChina
-
University of AlbertaActive, not recruiting
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