Targeted Fusion Biopsy of the Prostate

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.

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