PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PSMA -PET/CT scanning
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Ability to provide informed consent
- Metastatic prostate cancer.
- At least 18 years of age
- Standard imaging (bone scan, CT abdo/pelvis/chest) within 6 weeks of consent.
Exclusion Criteria:
-
Sites / Locations
- Centre Hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSMA -PET/CT scanning
Arm Description
Outcomes
Primary Outcome Measures
Metastasis detection yield
Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.
Secondary Outcome Measures
Reproducibility of PSMA radiotracer uptake
Measure the repeatability of PSMA PET/CT imaging.
Full Information
NCT ID
NCT03486886
First Posted
March 19, 2018
Last Updated
July 15, 2020
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03486886
Brief Title
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
Official Title
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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
A promising imaging technique involving new prostate specific membrane antigen (PSMA) positron emission tomography (PET) tracers is emerging in metastatic prostate cancer (PCa). This approach has demonstrated higher sensitivity in detecting metastases, prior to and during therapy, than current imaging standard of care (CT and bone scan).
PSMA is expressed in the vast majority of PCa tissue specimens and its degree of expression correlates with a number of important metrics of PCa tumor aggressiveness.
[18F]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. Studies employing second-generation PSMA PET/CT imaging in men with biochemical progression after definitive therapy suggest detection of metastases in over 60% of men imaged. In fact, PSMA-based PET has so far proven to have higher sensitivity than any other modality for localization of the site of recurrence. Applications that show promise and require further investigation include the characterization and risk stratification of primary PCa, complete staging of metastatic PCa to allow for PSMA-targeted radiotherapy and improved identification of patients with oligometastatic disease.
The objective of this study is to explore the detection yield of PSMA-PET in a pilot cohort of patients at CHUM and establish the repeatability of the technique before investigating it more widely.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSMA -PET/CT scanning
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA -PET/CT scanning
Intervention Description
PET/CT scanning is performed on hybrid PET/CT scanners. Patients should fast for at least 4 hours to facilitate transit of oral contrast into the distal small bowel. An oral contrast product can be administered and [18F]-DCFPyL is injected by IV rapid bolus followed by saline flush. 80-100 minutes following [18F]-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the upper thighs. An MRI of the questioned lesion sites may be performed.
Uptake of lesions is measured with SUVmax. Hepatic and blood pool SUV is determined for the computation of tumor-to-liver and tumor-to-blood ratios.
15 patients max will undergo a second PSMA-PET scan on the same camera with the same protocol using a different tracer batch within 2 weeks of the initial PSMA-PET evaluation in order to determine test-retest repeatability of the imaging procedure using a Bland-Altman analysis (per lesion analysis).
Primary Outcome Measure Information:
Title
Metastasis detection yield
Description
Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Reproducibility of PSMA radiotracer uptake
Description
Measure the repeatability of PSMA PET/CT imaging.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to provide informed consent
Metastatic prostate cancer.
At least 18 years of age
Standard imaging (bone scan, CT abdo/pelvis/chest) within 6 weeks of consent.
Exclusion Criteria:
-
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
We'll reach out to this number within 24 hrs