NCT02744534

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 8, 2019

Completed
Last Updated

May 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

April 15, 2016

Results QC Date

March 28, 2019

Last Update Submit

April 17, 2019

Conditions

Prostatic Neoplasms

Keywords

Prostate CancerImaging TechnologyOncologyProstate Biopsy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Cores Positive for Cancer

    The cancer detection rate per core was compared between the targeted prostate biopsy and standard of care prostate biopsy.

    Two weeks

Study Arms (2)

Abnormalities found with FACBC PET-CT

EXPERIMENTAL

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 ScanProcedure: Three-dimensional ultrasound-guided biopsyProcedure: Standard transrectal ultrasound (TRUS) guided biopsy

No abnormalities found with FACBC PET-CT

ACTIVE COMPARATOR

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 ScanProcedure: Standard transrectal ultrasound (TRUS) guided biopsy

Interventions

FACBC PET-CT ScanDRUG

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.

Abnormalities found with FACBC PET-CTNo abnormalities found with FACBC PET-CT
Three-dimensional ultrasound-guided biopsyPROCEDURE

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.

Also known as: Targeted prostate biopsy
Abnormalities found with FACBC PET-CT
Standard transrectal ultrasound (TRUS) guided biopsyPROCEDURE

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.

Also known as: Standard prostate biopsy
Abnormalities found with FACBC PET-CTNo abnormalities found with FACBC PET-CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Baowei Fei, PhD
Organization
Emory University
bfei@utdallas.edu
972-883-7239

Study Officials

  • Baowei Fei, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Georgia Cancer Coalition Distinguished Scholar

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 20, 2016

Study Start

November 1, 2015

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

May 8, 2019

Results First Posted

May 8, 2019

Record last verified: 2019-04

Locations

US(2)