A Phase 2 interventional study of FACBC PET-CT Scan and Three-dimensional ultrasound-guided biopsy in Prostatic Neoplasms, sponsored by Emory University. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-08.
Sponsored by Emory University · Phase 2, Interventional, and Diagnostic
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.
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, a synthetic amino acid, anti-1-amino-3-[18F]fluorocyclobutane-1- carboxylic acid (FACBC), 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:
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.
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This study's enrollment of 21 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
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 · Procedure: Three-dimensional ultrasound-guided biopsy · Procedure: Standard transrectal ultrasound (TRUS) guided biopsy
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 · Procedure: Standard transrectal ultrasound (TRUS) guided biopsy
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.
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
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
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.
Time frame: Two weeks
Participants were recruited from Emory University Hospital and the Winship Cancer Institute in Atlanta, Georgia from November 2015 to April 2017. All study procedures were completed by March 31, 2018.
| Milestone | Targeted Biopsy and Template Biopsy |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
The cancer detection rate per core was compared between the targeted prostate biopsy and standard of care prostate biopsy.
| percentage of positive core samples | Targeted Biopsy | Standard Biopsy |
|---|---|---|
| Percentage of Cores Positive for Cancer | 32.0 | 4.5 |
Collected over The time period for collecting adverse events was from the the time of the FACBC PET-CT scan until 7 days after the scan. Since 95% of the ligand used during the scan is eliminated within 7 days, any events beyond 7 days after the scan were not considered to be adverse events due to study procedures.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Targeted Biopsy | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Template Biopsy | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Targeted Biopsy and Template Biopsy |
|---|---|
| Mean | 69.6 ± 7.4 |
| Sex: Female, Male(Participants) | Targeted Biopsy and Template Biopsy |
|---|---|
| Female | 0 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | Targeted Biopsy and Template Biopsy |
|---|
| Region of Enrollment(Participants) | Targeted Biopsy and Template Biopsy |
|---|---|
| United States | 21 |
| Prostate-Specific Antigen (PSA) prior to PET scan(ng/ml) | Targeted Biopsy and Template Biopsy |
|---|---|
| Mean | 7.4 ± 6.8 |
| Initial therapy(Participants) | Targeted Biopsy and Template Biopsy |
|---|---|
| Radiotherapy | 9 |
| Non-radiotherapy (cryotherapy) | 3 |
| Mixed therapy | 9 |
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