Targeted Fusion Biopsy of the Prostate

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

March 31, 2018

Study Completion Date

March 31, 2018

Conditions
Prostatic Neoplasms
Interventions
DRUG

FACBC PET-CT Scan

"One hour prior to scanning, participants will drink one glass (450 ml) of oral contrast to allow for better pictures of abdomen and pelvic organs. The participants will have their temperature taken before and after the injection of the FACBC. Blood pressure and pulse will be taken every 15 minutes during the PET scan.~Participants will lie on a scanning bed and the bed will move slowly through the PET/CT scanner. This portion usually takes about one minute. Following this the FACBC will by administered by an intravenous (IV) catheter and the PET scan portion of the exam will begin. The table moves slowly through the scanner and many sets of PET-CT images are produced. When the imaging is complete, the scanner will send the results to a computer. The computer then generates a number of images that will be reviewed by a specially trained radiologist."

PROCEDURE

Three-dimensional ultrasound-guided biopsy

"A lubricated rectal probe will be inserted and a local anesthetic to numb the prostate will be administered. The ultrasound probe allows visualization of the prostate in two-dimensional (2D) images. The probe connects to a computer that will link to the FACBC PET-CT scan results that the participant has already had performed. These combined images will provide a three-dimensional (3D) image from the FACBC PET-CT scan previously obtained as well as real-time, 2D ultrasound images, resulting in an improved visualization tool to target the biopsy needle to a suspicious lesion.~The needle tip position for each biopsy sample will be recorded on the real-time ultrasound images; this information allows the physician to either re-biopsy the same area for a follow-up examination or not to re-biopsy the same region if the original biopsy was negative.~This biopsy process is estimated to take about 10 minutes."

PROCEDURE

Standard transrectal ultrasound (TRUS) guided biopsy

A lubricated ultrasound probe of about 2.5 cm in diameter is gently inserted into the rectum and a local anesthetic to numb the prostate is administered. The ultrasound probe allows visualization of the prostate in two-dimensional (2D) images and allows for the placement of a biopsy needle that collects samples of the prostate. Usually, a total of 12 biopsy specimens are collected. The procedure takes about 20 minutes. This TRUS-guided biopsy is considered as the standard method for prostate cancer diagnosis.

Trial Locations (2)

30322

Emory University Hospital, Atlanta

Emory University Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Emory University

OTHER

NCT02744534 - Targeted Fusion Biopsy of the Prostate | Biotech Hunter | Biotech Hunter