FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

David M. Schuster, MD

Status and phase

Terminated

Phase 2

Conditions

Prostate Cancers

Treatments

Drug: anti [18F]FACBC

Study type

Interventional

Funder types

Other

Identifiers

NCT00917865

FACBC (Other Identifier)

IRB00008094

Details and patient eligibility

About

The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer.

The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy.

The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells.

This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.

Enrollment

11 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be 18 years of age or older.
Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer.
Ability to lie still for PET scanning
Patients must be able to provide written informed consent.

Exclusion criteria

Age less than 18
Inability to lie still for PET scanning
Cannot provide written informed consent.
Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).