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Targeted Fusion Biopsy of the Prostate

This study is currently recruiting participants.
Verified October 2016 by Baowei Fei, PhD, EngD, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02744534
First Posted: April 20, 2016
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Baowei Fei, PhD, EngD, Emory University
  Purpose
The purpose of this study is to see if using Positron Emission Tomography (PET) scan and transrectal ultrasound (TRUS) guided biopsy together (creating a 3-dimensional ultrasound) will detect prostate cancer more accurately than the standard 2-dimensional approach which uses only the TRUS to guide the biopsy.

Condition Intervention Phase
Prostatic Neoplasms Drug: FACBC PET-CT Scan Procedure: Three-dimensional ultrasound-guided biopsy Procedure: Standard transrectal ultrasound (TRUS) guided biopsy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Fusion Biopsy of the Prostate

Resource links provided by NLM:


Further study details as provided by Baowei Fei, PhD, EngD, Emory University:

Primary Outcome Measures:
  • Comparison of cancer detection between standard and targeted prostate biopsies [ Time Frame: Two weeks ]
    The cancer detection rate per core will be compared between the standard care prostate biopsy and the targeted prostate biopsy.


Estimated Enrollment: 36
Study Start Date: November 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abnormalities found with FACBC PET-CT
All participants with suspected recurrence of prostate cancer will have the FACBC PET-CT scan performed. Participants with abnormal FACBC PET-CT scan results will have a PET/ultrasound fusion targeted prostate biopsy followed a standard of care prostate biopsy.
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.

Other Name: Targeted prostate biopsy
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.
Other Name: Standard prostate biopsy
Active Comparator: No abnormalities found with FACBC PET-CT
All participants with suspected recurrence of prostate cancer will have the FACBC PET-CT scan performed. Participants without abnormal FACBC PET-CT scan results will have a standard of care prostate biopsy.
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: 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.
Other Name: Standard prostate biopsy

Detailed Description:

The objective of the proposed study is to evaluate a molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. Prior studies have shown that Positron Emission Tomography (PET)/Computed Tomography (CT) imaging with the PET molecular imaging agent, FACBC (a synthetic amino acid), is more sensitive than the FDA-approved prostate specific membrane antigen single-photon emission computed tomography (SPECT) radiotracer in prostate cancer detection. FACBC images showed higher focal uptake in tumor foci than in normal prostate and thus could be ideal information to direct targeted biopsy of the prostate. This targeted biopsy system has a unique feature that PET/CT images can be registered with 3D ultrasound images, as a result, a suspicious PET lesion is superimposed over the real-time ultrasound data; and the fused image is then used to direct biopsy needles to tumor targets.

The hypothesis of the study is that PET/ultrasound fusion targeted biopsy can detect more cancer per core than the standard 12-core TRUS guided biopsy.

The specific aims include:

  1. To perform PET/CT directed, 3D ultrasound-guided biopsy and determine if fusion targeted biopsy can detect more cancers than 2D transrectal ultrasound (TRUS)-guided biopsy
  2. To develop the workflow for performing deformable registration and fusion of PET/CT and 3D ultrasound images of human patients

Thirty six patients, who have suspicion of recurrent prostate cancer after definitive therapy such as radiotherapy, will be recruited into this study. At least half of the patients will have positive imaging findings and will undergo 2D TRUS-guided biopsy as well as PET/ultrasound fusion biopsy. The proposed study will be the first-in-human trial that uses PET/CT imaging to direct 3D ultrasound-guided biopsy of the prostate. The multimodality imaging approach will combine the high sensitivity from PET and real-time information from ultrasound for improved cancer detection.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Patients must be 18 years of age or older

  • Have been originally diagnosed with prostate carcinoma and have undergone definitive non-prostatectomy therapy for localized disease
  • There is suspicion of recurrent prostate carcinoma as defined by: Older American Society for Radiation Oncology (ASTRO) criteria of three consecutive rises of prostate-specific antigen (PSA) or earlier if clinically appropriate, and/or nadir + 2.0 ng/ml (Radiation Therapy Oncology Group (RTOG)-ASTRO Phoenix criteria)
  • Able to provide written informed consent

Exclusion Criteria:

  • Cryotherapy, external beam radiation, or high intensity focused ultrasound (HIFU) within the past year
  • Brachytherapy within the past two years (to rule out a transient rise in PSA)
  • Prostate biopsy within the past month (to decrease a false positive result due to inflammation)
  • Not otherwise eligible for prostate biopsy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744534


Contacts
Contact: Baowei Fei, PhD (404) 712-5649 baowei.fei@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Baowei Fei, PhD, EngD    404-712-5649    baowei.fei@emory.edu   
Contact: Leah Bellamy, RN, MSN    404-712-7965    lbellam@emory.edu   
Sub-Investigator: Peter T Nieh, MD         
Sub-Investigator: Viraj A Master, MD         
Sub-Investigator: David M Schuster, MD         
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Baowei Fei, PhD    404-712-5649    baowei.fei@emory.edu   
Contact: Leah Bellamy, RN, MSN    404-712-7965    lbellam@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Baowei Fei, PhD Emory University
  More Information

Responsible Party: Baowei Fei, PhD, EngD, Associate Professor and Georgia Cancer Coalition Distinguished Scholar, Emory University
ClinicalTrials.gov Identifier: NCT02744534     History of Changes
Other Study ID Numbers: IRB00080287
First Submitted: April 15, 2016
First Posted: April 20, 2016
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Baowei Fei, PhD, EngD, Emory University:
Prostate Cancer
Imaging Technology
Oncology
Prostate Biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases