Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.

The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Resident of Canada
Male sex
Age 18 years or older
Previous diagnosis of prostate cancer with Gleason Score available
ECOG performance status 0 - 3, inclusive
Able to understand and provide written informed consent
Under referring physician's care
Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation

Exclusion criteria

Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
Patients with unmanageable claustrophobia

Treatment and study plan

18F-DCFPyL PET/CT

Drug

18F-DCFPyL PET/CT

Primary outcomes

SUVmax on 18F-DCFPyL PET/CT

Time frame: 24 hours

Maximum standard uptake value (SUVmax) on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Dec 23, 2016
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed