18F-DCFBC PET/CT in Prostate Cancer
18F-DCFBC PET/CT in Prostate Cancer
Background:

 - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical
 called a radiotracer helps doctors get images of this type of cancer. Researchers want to
 test a radiotracer called
 N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
 (18F-DCFBC).

 Objective:

 - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body.

 Eligibility:

 - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have
 relapsed, or has spread outside the prostate.

 Design:

 -  Participants will be screened with physical exam and medical history. They will give a
 blood sample.

 -  Participants will be divided into three groups.

 Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or
 biopsy at National Institutes of Health (NIH).

 Group 2: people who had their prostate removed or had radiation therapy and now have a rising
 prostate-specific antigen (PSA) without other signs of disease.

 Group 3: people whose cancer has spread to other areas of the body.

 -  Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission
 tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on
 their back on the scanner table.

 -  Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the
 rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a
 contrast agent injected through an intravenous line.

 -  Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21
 days of the 18F-DCFBC scan to look for prostate cancer in the bone.

 -  Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans.

 -  A few days after each scan, participants will be contacted for follow-up.
Background

 -  Prostate cancer is the second leading cause of cancer deaths in American men.

 -  Current methods of imaging advanced prostate cancer (computed tomography ((CT) and bone
 scan) are non specific and new, more specific molecular imaging probes are sought.

 -  Many prostate cancers express the prostate specific membrane antigen (PSMA) a
 transmembrane protein with N-acetylated alpha-linked acidic dipeptidase (NAALADase)
 enzymatic activity. PSMA is also expressed in angiogenesis but otherwise has limited
 expression in normal tissue.

 -  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)
 (18F-DCFBC) is a radiolabeled positron emission tomography (PET) agent which binds with
 high affinity to PSMA and through whole-body non-invasive functional imaging, may
 provide new information on the expression of PSMA.

 Primary Objective

 - To assess the ability of 18F-DCFBC to differentiate between tumorous and nontumorous
 tissues in localized, recurrent (based on rising prostatic-specific antigen ((PSA) post
 treatment) and metastatic prostate cancer

 Eligibility

 -  Subject is greater than or equal to 18 years old

 -  Eastern Cooperative Oncology Group (ECOG) 0-2 with adenocarcinoma of the prostate and
 fits criteria for one of the following:

 -  ARM 1

 -- Patients with known localized prostate cancer with a soft tissue lesion at least 6mm
 or greater.

 ---A multiparametric magnetic resonance imaging (MRI) (standard of care at the National
 Institutes of Health ((NIH) Clinical Center) must be performed within 4 months
 of18F-DCFBC injection with findings suggestive for prostate cancer and confirmed with
 histopathology.

 -  ARM 2

 -  Patients with biochemical prostate cancer relapse after definitive treatment

 -  For patients status post radiation therapy for prostate cancer, a PSA increase
 from post radiation therapy nadir

 -  OR

 -  For patients status post prostatectomy, any PSA >/=0.2 ng/ml

 -  Nonspecific or no evidence for disease on standard imaging modality

 -  ARM 3

 -  Patients with identifiable metastatic disease on a conventional imaging modality.
 If only soft tissue metastasis, one lesion must measure 6mm or greater. Patients
 must have confirmation of prostate cancer prior to 18F-DCFBC imaging.

 Design

 This is a single site 3-arm study enrolling a total of 110 evaluable patients: Arm 1 will
 include 12 patients with presumed localized prostate cancer scheduled to undergo
 prostatectomy or biopsy within 4 months of enrollment; Arm 2 will include 78 patients with
 biochemical recurrence without evidence of metastasis on conventional imaging; and Arm 3 will
 include 20 patients with known metastatic disease who may or may not be on or/scheduled to
 begin therapeutic intervention. Patients with presumed localized disease will undergo a
 standard of care, clinical multiparametric endorectal coil MRI in the National Cancer
 Institute (NCI) Molecular Imaging Clinic within 4 months of screening. Patients in Arm 3 will
 undergo 2 imaging sessions: baseline and 4-6 month follow-up. Clinical records (including
 PSA) and treatment (if any) that occurred in the imaging interval must be available. All
 patients in Arm 3 will also undergo Na18F PET/CT for evaluation of bone metastases as part of
 this protocol. In order to allow for a small number of nonevaluable patients, the accrual
 ceiling will be set at 125.
-  INCLUSION CRITERIA:

 -  Subject is greater than or equal to18 years old

 -  Platelet count > 50,000/mm^3

 -  Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

 -  Ability to provide informed consent. All subjects must sign an informed consent form
 indicating their understanding of the investigational nature and risks of the study
 before any protocol-related studies are performed.

 -  Categories

 -  ARM 1 only

 ---For patients with presumed localized disease (any tumor (T), nodes 0 (N0),
 metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI)
 (standard of care at the National Institutes of Health ((NIH) Clinical Center)
 must be performed within 4 months of the
 N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine
 ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer
 and a prostate lesion at least 6mm or greater. Must have histopathologic
 confirmation of prostate cancer prior to 18F-DCFBC imaging.

 -  ARM 2 only:

 -  For patients status post radiation therapy for prostate cancer, any
 prostatic-specific antigen (PSA) increase from post radiation therapy nadir

 -  OR

 -  For patients status post prostatectomy, a PSA >/=0.2 ng/ml

 -  Nonspecific or no evidence for disease on standard imaging modality

 -  ARM 3 only:

 -  Patients must have identifiable metastatic disease on at least 1 clinically
 indicated imaging modality. If only soft tissue metastasis, one lesion must
 measure at least 6mm or greater. Patients must have confirmation of prostate
 cancer prior to 18FDCFBC imaging

 Note: A patient who is eligible for one arm, subsequently may cross-over into a different
 arm.

 EXCLUSION CRITERIA:

 -  Subjects for whom participating would significantly delay the scheduled standard of
 care therapy

 -  Subjects with any coexisting medical or psychiatric condition that is likely to
 interfere with study procedures and/or results.

 -  Subjects with severe claustrophobia unresponsive to oral anxiolytics

 -  Other medical conditions deemed by the principal investigator (or associates) to make
 the subject unsafe/ineligible for protocol procedures.

 -  Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within
 the imaging gantry

 -  Serum creatinine > 2 times the upper limit of normal

 -  Total bilirubin > 2 times the upper limit of normal

 -  Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST))
 greater than 3 times the upper limit of normal