18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 3/14/2019 |
| Start Date: | June 6, 2017 |
| End Date: | June 30, 2025 |
| Contact: | Yolanda McKinney, R.N. |
| Email: | ymckinney@mail.nih.gov |
| Phone: | (240) 760-6095 |
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
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
Tomography/Computed Tomography (PET/CT). 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 PET/CT.
Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic
Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT
imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of
the pelvis.
If the 18F-DCFPyL PET/CT 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
Tomography/Computed Tomography (PET/CT). 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 PET/CT.
Participants will be contacted 1 3 days later for follow-up. They may undergo PET/Magnetic
Resonance Imaging (MRI) either after having a 18F-DCFPyL PET/CT, or in place of PET/CT
imaging. A tube may be placed in the rectum. More coils may be wrapped around the outside of
the pelvis.
If the 18F-DCFPyL PET/CT 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.
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) PET/CT (or
PET/MRI 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)-PET/CT imaging and all sites of suspected disease detected by [18F]
Fluorodeoxyglucose (FDG) for prostate cancer.
OBJECTIVES:
- To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to
NaF-PET/CT 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
- Radiologic evidence of metastatic bone disease demonstrated on anatomical imaging (CT,
MRI, or ultrasound), bone scintigraphy, [^18F] Sodium Fluoride (NaF)-PET, and/or [^18F]
FDG PET
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- 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.
DESIGN:
- Two Cohort study
- Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to
or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart).
- Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value
obtained on at least two occasions within 1 year
- Patients will undergo DCFPyL PET/CT (or PET/MRI) and NaF-PET/CT FDG
PET/CT within 21 days of each other. The order obtained does not matter.
- The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and
standard chest/abdomen/pelvis CT
- DCFPyL PET/CT (or PET/MRI) 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 by chart review, phone-call, and/or email follow-up for
PSA relapse and radiologic evidence of metastatic disease over a one-year period from
the time of imaging.
- The objective of this study is to evaluate a radiolabeled urea-based small molecule
inhibitor of prostate-specific membrane antigen (PSMA), [18F] DCFPyL (DCFPyL) PET/CT (or
PET/MRI 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)-PET/CT imaging and all sites of suspected disease detected by [18F]
Fluorodeoxyglucose (FDG) for prostate cancer.
OBJECTIVES:
- To compare the diagnostic sensitivity of DCFPyL-PET/CT (or PET/MRI imaging if available) to
NaF-PET/CT 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
- Radiologic evidence of metastatic bone disease demonstrated on anatomical imaging (CT,
MRI, or ultrasound), bone scintigraphy, [^18F] Sodium Fluoride (NaF)-PET, and/or [^18F]
FDG PET
- Age greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- 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.
DESIGN:
- Two Cohort study
- Cohort 1: Stable/Decreasing Prostate Specific Antigen (PSA): PSA must be equal to
or less than 0.5 ng/mL value of the last PSA obtained (at least one month apart).
- Cohort 2: Rising PSA: PSA must be greater than 0.5 ng/mL above the last PSA value
obtained on at least two occasions within 1 year
- Patients will undergo DCFPyL PET/CT (or PET/MRI) and NaF-PET/CT FDG
PET/CT within 21 days of each other. The order obtained does not matter.
- The DCFPyL PET/CT (or PET/MRI) will be compared with the NaF-PET/CT and FDG PET/CT and
standard chest/abdomen/pelvis CT
- DCFPyL PET/CT (or PET/MRI) 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 by chart review, phone-call, and/or email follow-up for
PSA relapse and radiologic evidence of metastatic disease over a one-year period from
the time of imaging.
- INCLUSION CRITERIA:
- Subject is greater than or equal to 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- Ability of subject to understand and the willingness to sign a written informed
consent document.
- Patients must have 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.
- Histological confirmation of prostate cancer
- Patients must be willing to undergo mandatory research biopsy
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 greater than 350 lbs. (weight limit for scanner table), or unable to
fit within the imaging gantry
- Serum creatinine greater than 2 times the upper limit of normal
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 888-624-1937
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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