Targeted Fusion Biopsy of the Prostate
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: FACBC PET-CT Scan; Three-dimensional ultrasound-guided biopsy; Standard transrectal ultrasound (TRUS) guided biopsy
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Imaging Technology; Oncology; Prostate Biopsy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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