Prostate Cancer Clinical Trial
Official title:
PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility
NCT number | NCT03486886 |
Other study ID # | 17.068 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2017 |
Est. completion date | April 30, 2018 |
Verified date | March 2018 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metastasis detection yield | Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging. | 6 weeks | |
Secondary | Reproducibility of PSMA radiotracer uptake | Measure the repeatability of PSMA PET/CT imaging. | 2 weeks |
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