Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.

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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 and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tripler Army Medical Center

Tripler AMC, Hawaii, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion criteria

Weight > 300 lb

Treatment and study plan

Fluourine-18 Fluoromethylcholine PET/CT Imaging

Device

Single-dose Study

Other names: 18F-choline PET/CT, Fluorocholine PET/CT

Primary outcomes

Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis

Time frame: Immediate - no longitudinal data collected

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

United States Department of Defense

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Mar 8, 2011
Registry last updated: Jul 22, 2022

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