18F-DCFBC PET/CT in Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 9/29/2018 |
| Start Date: | July 12, 2014 |
| End Date: | January 11, 2018 |
A Pilot Study of 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 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 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 PET/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.
- 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 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 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 PET/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 (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 NAALADase enzymatic activity. PSMA is also expressed in
angiogenesis but otherwise has limited expression in normal tissue.
- 18F-DCFBC is a radiolabeled 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 PSA post treatment) and metastatic prostate
cancer
Eligibility
- Subject is greater than or equal to 18 years old
- 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 MRI (standard of care at the 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-DCFBCimaging.
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 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.
- Prostate cancer is the second leading cause of cancer deaths in American men.
- Current methods of imaging advanced prostate cancer (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 NAALADase enzymatic activity. PSMA is also expressed in
angiogenesis but otherwise has limited expression in normal tissue.
- 18F-DCFBC is a radiolabeled 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 PSA post treatment) and metastatic prostate
cancer
Eligibility
- Subject is greater than or equal to 18 years old
- 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 MRI (standard of care at the 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-DCFBCimaging.
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 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 T, N0, M0), a
multiparametric MRI (standard of care at the NIH Clinical Center) must be
performed within 4 months of the 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 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 18FDCFBCimaging
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 (ALT, AST) greater than 3 times the upper limit of normal
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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