Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02190279
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2014-07-12
Brief Title:
18F-DCFBC PETCT in Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of 18F-DCFBC PETCT in Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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-13-dicarboxypropylcarbamoyl-4-18F-fluorobenzyl-L-cysteine 18F-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 PETcomputed 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 PETCT 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 PETCT 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 N-N-S-13-dicarboxypropylcarbamoyl-4-18F-fluorobenzyl-L-cysteine 18F-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 PETcomputed 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 PETCT 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 PETCT scans 4-6 months after the initial scans
A few days after each scan participants will be contacted for follow-up
Detailed Description:
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-13-dicarboxypropylcarbamoyl-4-18F-fluorobenzyl-L-cysteine 18F-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 02 ngml
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 orscheduled 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 PETCT 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 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-13-dicarboxypropylcarbamoyl-4-18F-fluorobenzyl-L-cysteine 18F-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 02 ngml
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 orscheduled 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-C-0140 | None | None | None |