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Clinical Trials/NCT03486886
NCT03486886
Completed
Not Applicable

PSMA-PET Imaging in Patients With Metastatic Prostate Cancer: Institutional Evaluation of Detection Yield Performance and Reproducibility

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country29 target enrollmentOctober 2, 2017
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
29
Locations
1
Primary Endpoint
Metastasis detection yield
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2017
End Date
April 30, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Metastasis detection yield

Time Frame: 6 weeks

Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.

Secondary Outcomes

  • Reproducibility of PSMA radiotracer uptake(2 weeks)

Study Sites (1)

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