Back to resultsPSMA PET/CT for Prostate Cancer (NGP2)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
[18F]PSMA-11
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, biochemical recurrence, 18F-PET imaging
Eligibility Criteria
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)
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Evaluation of effective targeting of prostate cancer and eventual metastases
Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases
Determination of the optimal scan protocol: define optimal time of scanning
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
Determination of the optimal scan protocol: define optimal scan duration
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
Determination of the optimal scan protocol: define optimal dose
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
Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol
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
Secondary Outcome Measures
Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans
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
Evaluation of the diagnostic specificity of [18F]PSMA-11
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:
In case the treating physician opts to perform a radical prostatectomy or lymphadenectomy or to take a biopt, the anatomopathological diagnosis (PSMA expression in tissue) will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
In case the treating physician opts for radiotherapy or hormone therapy, the (change in) PSA levels will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
In case the treating physician opts to acquire an additional MRI, suspicious lesions on the MRI will be also compared with those observed on the [18F]PSMA PET/CT scan.
Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03573011
Brief Title
PSMA PET/CT for Prostate Cancer
Acronym
NGP2
Official Title
PSMA-PET/CT for Prostate Cancer - Phase 2 Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
February 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, biochemical recurrence, 18F-PET imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Original phase 2 (44 subjects) Concerning the dose of [18F]PSMA-11, half of the patients in the phase 2 study will be injected with 2.0 ± 0.2 MBq/kg bodyweight. The other half will be injected with 4.0 ± 0.4 MBq/kg body weight. Randomization of patients to one of these two groups will be performed using a block randomization design with block sizes of two, four, and six.
Extension phase 2 (22 subjects):
For this part of the phase 2 study, all patients will be injected with 2.0 ± 0.2 MBq/kg bodyweight [18F]PSMA-11. No Randomisation or masking is applicable for this group of 22 subjects.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Original phase 2 trial (44 subjects)
The assigned [18F]PSMA-11 dosing group will be blind to the recruiting physicians, the patient the staff member(s) while planning the [18F]PSMA-11 scanday of the patient, and the nuclear medicine physicians interpreting the images.
Next to the clinical trial coordinators, also the staff members responsible for the preparation of the individual [18F]PSMA-11 dose and the IV injection of this dose are aware of the dose group (2.0 ± 0.2 or 4.0 ± 0.4 MBq/kg body weight), which means that they are NOT blinded. However, these staff members do not carry out any further study specific handlings.
Extension phase 2 trial (22 subjects):
masking is not applicable for this part of the phase 2 trial.
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
Arm Type
Experimental
Arm Description
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.
Arm Title
4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]PSMA-11
Intervention Description
18F-PET imaging
Primary Outcome Measure Information:
Title
Evaluation of effective targeting of prostate cancer and eventual metastases
Description
Two PET/CT scans with [18F]PSMA-11 will be acquired to evaluate the effectiveness of targeting prostate cancer and eventual metastases
Time Frame
0 to 3.5 hours post radiotracer injection
Title
Determination of the optimal scan protocol: define optimal time of scanning
Description
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
Time Frame
0 to 3.5 hours post radiotracer injection
Title
Determination of the optimal scan protocol: define optimal scan duration
Description
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
Time Frame
0 to 3.5 hours post radiotracer injection
Title
Determination of the optimal scan protocol: define optimal dose
Description
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
Time Frame
0 to 3.5 hours post radiotracer injection
Title
Determination of the optimal scan protocol: evaluation of the added value of furosemide (to improve diuresis), as part of the standard scanprotocol
Description
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
Time Frame
0 to 1.5 hours post radiotracer injection
Secondary Outcome Measure Information:
Title
Evaluation of the inter-observer difference for interpretation of [18F]PSMA-11 scans
Description
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
Time Frame
0 - 60 days post [18F]PSMA-11 administration
Title
Evaluation of the diagnostic specificity of [18F]PSMA-11
Description
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:
In case the treating physician opts to perform a radical prostatectomy or lymphadenectomy or to take a biopt, the anatomopathological diagnosis (PSMA expression in tissue) will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
In case the treating physician opts for radiotherapy or hormone therapy, the (change in) PSA levels will be used as an endpoint for correlation with the results of the [18F]PSMA scan.
In case the treating physician opts to acquire an additional MRI, suspicious lesions on the MRI will be also compared with those observed on the [18F]PSMA PET/CT scan.
Time Frame
0 - 60 days post [18F]PSMA-11 administration
Title
Evaluation of the impact of the [18F]PSMA-11 scan on the choice of therapy
Description
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.
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
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male with prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piet Ost, Prof.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
32095919
Citation
Piron S, De Man K, Schelfhout V, Van Laeken N, Kersemans K, Achten E, De Vos F, Ost P. Optimization of PET protocol and interrater reliability of 18F-PSMA-11 imaging of prostate cancer. EJNMMI Res. 2020 Feb 24;10(1):14. doi: 10.1186/s13550-020-0593-7.
Results Reference
derived
Learn more about this trial
PSMA PET/CT for Prostate Cancer
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