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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: PSMA -PET/CT scanning

• Registration Number: NCT03486886
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Status Verified: 2018-03
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSMA -PET/CT scanning	PSMA -PET/CT scanning	-

Primary Outcome Measures

Name	Time	Method
Metastasis detection yield	6 weeks	Evaluation of the metastasis detection yield between PSMA PET/CT and standard imaging.

Secondary Outcome Measures

Name	Time	Method
Reproducibility of PSMA radiotracer uptake	2 weeks	Measure the repeatability of PSMA PET/CT imaging.

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada