Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03173924
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2017-05-31
Brief Title:
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09-26
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 Few options exist to create images of this type of cancer Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body
Objective
To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease
Eligibility
People ages 18 and older who have metastatic prostate cancer
Design
Participants will be screened with
Blood tests
Physical exam
Medical history
Participants will be assigned to 1 of 2 groups based on their PSA
Participants will have 18F-DCFPyL injected into a vein About 2 hours later they will have a whole-body Positron Emission
TomographyComputed Tomography PETCT For the scan they will lie on their back on the scanner table while it takes pictures of the body This lasts about 50 minutes
On another day participants will have 18F -NaF injected into a vein About 1 hour later they will have a whole-body PETCT
Participants will be contacted 1 3 days later for follow-up They may undergo PETMagnetic Resonance Imaging MRI either after having a 18F-DCFPyL PETCT or in place of PETCT imaging A tube may be placed in the rectum More coils may be wrapped around the outside of the pelvis
If the 18F-DCFPyL PETCT is positive participants will be encouraged to undergo a biopsy of one of the tumors The biopsy will be taken through a needle put through the skin into the tumor
Participants will be followed for 1 year During this time researchers will collect information about their prostate cancer such as PSA levels and biopsy results
About 4-6 months after scanning is completed participants may have a tumor biopsy The biopsy will be taken through a needle put through the skin into the tumor
Prostate cancer is the second leading cause of cancer deaths in American men Few options exist to create images of this type of cancer Researchers think an experimental radiotracer called 18F-DCFPyL could find sites of cancer in the body
Objective
To see if 18F-DCFPyL can identify sites of prostate cancer in people with the disease
Eligibility
People ages 18 and older who have metastatic prostate cancer
Design
Participants will be screened with
Blood tests
Physical exam
Medical history
Participants will be assigned to 1 of 2 groups based on their PSA
Participants will have 18F-DCFPyL injected into a vein About 2 hours later they will have a whole-body Positron Emission
TomographyComputed Tomography PETCT For the scan they will lie on their back on the scanner table while it takes pictures of the body This lasts about 50 minutes
On another day participants will have 18F -NaF injected into a vein About 1 hour later they will have a whole-body PETCT
Participants will be contacted 1 3 days later for follow-up They may undergo PETMagnetic Resonance Imaging MRI either after having a 18F-DCFPyL PETCT or in place of PETCT imaging A tube may be placed in the rectum More coils may be wrapped around the outside of the pelvis
If the 18F-DCFPyL PETCT is positive participants will be encouraged to undergo a biopsy of one of the tumors The biopsy will be taken through a needle put through the skin into the tumor
Participants will be followed for 1 year During this time researchers will collect information about their prostate cancer such as PSA levels and biopsy results
About 4-6 months after scanning is completed participants may have a tumor biopsy The biopsy will be taken through a needle put through the skin into the tumor
Detailed Description:
Background
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen PSMA 18F DCFPyL DCFPyL PETCT or PETMRI imaging if available for detection of metastatic prostate cancer
PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential
Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound DCFBC in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection
We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific 18F Sodium Fluoride NaF-PETCT imaging and all sites of suspected disease detected by 18F Fluorodeoxyglucose FDG for prostate cancer
Objective
To compare the diagnostic sensitivity of DCFPyL-PETCT or PETMRI imaging if available to NaF-PETCT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities CIM such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available
Eligibility
Histological confirmation of prostate cancer
Age 18 years old
Eastern Cooperative Oncology Group ECOG performance score of 0 to 2
Patients must have either
Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality If there is only soft tissue metastasis one lesion must measure at least 6 mm or greater OR
Documented history of metastatic prostate cancer
Design
Two Cohort study
Cohort 1 StableDecreasing Prostate Specific Antigen PSA PSA must be equal to or less than 05 ngmL value of the last PSA obtained at least one month apart
Cohort 2 Rising PSA PSA must be greater than 05 ngmL above the last PSA value obtained on at least two occasions within 1 year
Patients will undergo DCFPyL PETCT or PETMRI NaF-PETCT and FDG PETCT within 21 days of each other The order obtained does not matter
The DCFPyL PETCT or PETMRI will be compared with the NaF-PETCT and FDG PETCT and standard chestabdomenpelvis CT
DCFPyL PETCT or PETMRI detection of metastatic disease will be assessed by visual qualitative assessment as positive equivocal or negative Sites of equivocal or positive metastatic disease will have a quantitative PET assessment SUVmax SUVmean
A mandatory research biopsy will be performed under image guidance on a suspicious lesion if feasible
The patients will be followed yearly for 4 years by chart review phone-call email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease Additional 18F-DCFPyL and 18F-FDG PETCTs might be performed during the subject s follow up period there has been a considerable change in patient status progression or response based on PSA value symptomatology bone scan or CT findings
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen PSMA 18F DCFPyL DCFPyL PETCT or PETMRI imaging if available for detection of metastatic prostate cancer
PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential
Our preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound DCFBC in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection
We propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis Correlation will be made to sites of suspected bony metastatic disease detected by ultra-sensitive but less specific 18F Sodium Fluoride NaF-PETCT imaging and all sites of suspected disease detected by 18F Fluorodeoxyglucose FDG for prostate cancer
Objective
To compare the diagnostic sensitivity of DCFPyL-PETCT or PETMRI imaging if available to NaF-PETCT for detection of prostate cancer bone metastasis based on comparison to reference standard of care conventional imaging modalities CIM such as CT and whole body bone scintigraphy incorporating prior and follow-up scans and histopathology when available
Eligibility
Histological confirmation of prostate cancer
Age 18 years old
Eastern Cooperative Oncology Group ECOG performance score of 0 to 2
Patients must have either
Confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality If there is only soft tissue metastasis one lesion must measure at least 6 mm or greater OR
Documented history of metastatic prostate cancer
Design
Two Cohort study
Cohort 1 StableDecreasing Prostate Specific Antigen PSA PSA must be equal to or less than 05 ngmL value of the last PSA obtained at least one month apart
Cohort 2 Rising PSA PSA must be greater than 05 ngmL above the last PSA value obtained on at least two occasions within 1 year
Patients will undergo DCFPyL PETCT or PETMRI NaF-PETCT and FDG PETCT within 21 days of each other The order obtained does not matter
The DCFPyL PETCT or PETMRI will be compared with the NaF-PETCT and FDG PETCT and standard chestabdomenpelvis CT
DCFPyL PETCT or PETMRI detection of metastatic disease will be assessed by visual qualitative assessment as positive equivocal or negative Sites of equivocal or positive metastatic disease will have a quantitative PET assessment SUVmax SUVmean
A mandatory research biopsy will be performed under image guidance on a suspicious lesion if feasible
The patients will be followed yearly for 4 years by chart review phone-call email or any other NIH approved platform for PSA relapse and radiologic evidence of metastatic disease Additional 18F-DCFPyL and 18F-FDG PETCTs might be performed during the subject s follow up period there has been a considerable change in patient status progression or response based on PSA value symptomatology bone scan or CT findings
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 |
|---|---|---|---|
| 17-C-0089 | None | None | None |