PSMA PET/CT for Prostate Cancer (NGP2)
May 2, 2019 updated by: University Hospital, Ghent
PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
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 Prostate Specific Antigen (PSA) 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
|
|
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
|
Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases
|
0 to 3.5 hours post radiotracer injection
|
|
Determination of the optimal scan protocol: define optimal time of scanning
Time Frame: 0 to 3.5 hours post radiotracer injection
|
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
|
0 to 3.5 hours post radiotracer injection
|
|
Determination of the optimal scan protocol: define optimal scan duration
Time Frame: 0 to 3.5 hours post radiotracer injection
|
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
|
0 to 3.5 hours post radiotracer injection
|
|
Determination of the optimal scan protocol: define optimal dose
Time Frame: 0 to 3.5 hours post radiotracer injection
|
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
|
0 to 3.5 hours post radiotracer injection
|
|
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
|
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
|
0 to 1.5 hours post radiotracer injection
|
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
|
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
|
0 - 60 days post [18F]PSMA-11 administration
|
|
Evaluation of the diagnostic specificity of [18F]PSMA-11
Time Frame: 0 - 60 days post [18F]PSMA-11 administration
|
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:
|
0 - 60 days post [18F]PSMA-11 administration
|
|
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
|
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2018
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
February 18, 2019
Study Registration Dates
First Submitted
June 19, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 28, 2018
Study Record Updates
Last Update Posted (Actual)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 2, 2019
Last Verified
January 1, 2019
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
No
Studies a U.S. FDA-regulated device product
No
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