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

July 15, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada
        • Centre Hospitalier de l'Universite de Montreal

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

All

Description

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:

-

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA -PET/CT scanning
Diagnostic test: PSMA -PET/CT scanning

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastasis detection yield
Time Frame: 6 weeks
Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility of PSMA radiotracer uptake
Time Frame: 2 weeks
Measure the repeatability of PSMA PET/CT imaging.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

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)

October 2, 2017

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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