18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/4/2019 |
| Start Date: | August 3, 2017 |
| End Date: | October 1, 2022 |
| Contact: | Yolanda McKinney, R.N. |
| Email: | ymckinney@mail.nih.gov |
| Phone: | (240) 760-6095 |
(18)F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Background:
Prostate cancer is the second leading cause of cancer deaths in American men. When prostate
cancer is confined to the prostate there is a high chance of cure. However, it is outside the
prostate or comes back after treatment, additional therapy may be needed. Current methods of
imaging prostate cancer are limited. Researchers want to see if a radiotracer called
18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading
outside the prostate or who have signs of recurrent cancer after treatment.
Objectives:
To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or
after therapy.
Eligibility:
Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed
after radiation or surgery
Design:
Participants will be screened with medical history and physical exam. They will have blood
taken.
Participants will be divided into 2 groups.
- Group 1 will be men with cancer that has been newly diagnosed as high risk by their
doctor who are scheduled to have prostate removal surgery or undergo biopsy before
radiation therapy.
- Group 2 will be men who have presumed prostate cancer relapse after prostate removal
surgery or radiation therapy.
Both groups will have scans taken. Participants will lie still on a table in a machine that
takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.
Participants will be contacted for follow-up after scans.
Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove
some prostate tissue. This procedure will be standard of care and is not a part of this
study. They will also have an extra MRI scan of their prostate. For this, a tube, called an
endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside
of their pelvis. A contrast agent will be given by IV.
Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of
abnormalities found on the 18F-DCFyL scan.
Participants will have data about their prostate cancer collected for up to 1 year.
Prostate cancer is the second leading cause of cancer deaths in American men. When prostate
cancer is confined to the prostate there is a high chance of cure. However, it is outside the
prostate or comes back after treatment, additional therapy may be needed. Current methods of
imaging prostate cancer are limited. Researchers want to see if a radiotracer called
18F-DCFPyL can identify prostate cancer in patients who have a high risk of cancer spreading
outside the prostate or who have signs of recurrent cancer after treatment.
Objectives:
To see if the radiotracer 18F-DCFyL can help identify prostate cancer in the body before or
after therapy.
Eligibility:
Men ages 18 and older who have prostate cancer that has been newly diagnosed, or has relapsed
after radiation or surgery
Design:
Participants will be screened with medical history and physical exam. They will have blood
taken.
Participants will be divided into 2 groups.
- Group 1 will be men with cancer that has been newly diagnosed as high risk by their
doctor who are scheduled to have prostate removal surgery or undergo biopsy before
radiation therapy.
- Group 2 will be men who have presumed prostate cancer relapse after prostate removal
surgery or radiation therapy.
Both groups will have scans taken. Participants will lie still on a table in a machine that
takes pictures of their body. 18F-DCFyL will be injected by intravenous (IV) line.
Participants will be contacted for follow-up after scans.
Participants in Group 1 may have surgery to remove their prostate gland or a biopsy to remove
some prostate tissue. This procedure will be standard of care and is not a part of this
study. They will also have an extra MRI scan of their prostate. For this, a tube, called an
endorectal coil, will be placed in their rectum. Other tubes may be wrapped around the inside
of their pelvis. A contrast agent will be given by IV.
Participants in Group 2 may also undergo an MRI of the pelvis and may have a biopsy of
abnormalities found on the 18F-DCFyL scan.
Participants will have data about their prostate cancer collected for up to 1 year.
Background
- Prostate cancer (PCa) is the second leading cause of cancer death in American men.
- Patients with high risk but apparently localized disease are often understaged because
disease beyond the prostate is not well detected and thus leads to overtreatment with
prostatectomy
- Recurrence of PCa after surgery or radiation is very common and sometimes progresses to
death.
- Early intervention for recurrence has been shown to be of benefit but current methods of
localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone
scan) Many prostate cancers express the prostate specific membrane antigen (PSMA) a
transmembrane protein with NAALADase (N-acetylated-alphalinked- acidic dipeptidase) and
folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but
otherwise has limited expression in normal tissue.
- An initial test of (18)F-DCFBC, a first-generation PET agent targeting PSMA, in patients
with advanced local disease and biochemically recurrent prostate cancer demonstrated the
potential of PET to detect sites of recurrence but it was hampered by excessive blood
pool activity.
- (18)F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet
clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may
provide a new tool in staging high risk cancers and detecting recurrent disease.
Primary Objective
- To assess the ability of (18)F-DCFPyL to accurately stage high-risk primary prostate cancer
and detect sites of recurrent prostate cancer.
Eligibility
- Age greater than or equal to 18 years old
- ECOG 0-2
- Histologically confirmed adenocarcinoma of the prostate
- Patients fit criteria for one of the following categories:
- Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or
clinical stage greater than or equal to T2c) with evidence of disease on standard
imaging, or
- Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND
biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/ml
Design
This is a single site study enrolling a total of 330 patients; 55 patients with presumed
localized high risk prostate cancer scheduled to undergo prostatectomy or biopsy within 4
months of enrollment and 275 patients with suspected recurrent prostate cancer without
definitive evidence of disease on conventional imaging. All patients will undergo a standard
of care, clinical multiparametric endorectal coil MRI in the NCI Molecular Imaging Clinic
within 4 months of the PET scan.
- Prostate cancer (PCa) is the second leading cause of cancer death in American men.
- Patients with high risk but apparently localized disease are often understaged because
disease beyond the prostate is not well detected and thus leads to overtreatment with
prostatectomy
- Recurrence of PCa after surgery or radiation is very common and sometimes progresses to
death.
- Early intervention for recurrence has been shown to be of benefit but current methods of
localizing recurrence are either insensitive (CT), non-specific (MRI) or both (bone
scan) Many prostate cancers express the prostate specific membrane antigen (PSMA) a
transmembrane protein with NAALADase (N-acetylated-alphalinked- acidic dipeptidase) and
folate hydrolase enzymatic activity. PSMA is also expressed in angiogenesis but
otherwise has limited expression in normal tissue.
- An initial test of (18)F-DCFBC, a first-generation PET agent targeting PSMA, in patients
with advanced local disease and biochemically recurrent prostate cancer demonstrated the
potential of PET to detect sites of recurrence but it was hampered by excessive blood
pool activity.
- (18)F-DCFPyL, a second generation PSMA PET agent, binds with high affinity to PSMA yet
clears rapidly from the blood pool and thus, whole-body PET imaging with this agent, may
provide a new tool in staging high risk cancers and detecting recurrent disease.
Primary Objective
- To assess the ability of (18)F-DCFPyL to accurately stage high-risk primary prostate cancer
and detect sites of recurrent prostate cancer.
Eligibility
- Age greater than or equal to 18 years old
- ECOG 0-2
- Histologically confirmed adenocarcinoma of the prostate
- Patients fit criteria for one of the following categories:
- Cohort 1: known localized high risk prostate cancer (PSA >10, Gleason 8-10 or
clinical stage greater than or equal to T2c) with evidence of disease on standard
imaging, or
- Cohort 2: nonspecific or no evidence of disease on standard imaging modality AND
biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/ml
Design
This is a single site study enrolling a total of 330 patients; 55 patients with presumed
localized high risk prostate cancer scheduled to undergo prostatectomy or biopsy within 4
months of enrollment and 275 patients with suspected recurrent prostate cancer without
definitive evidence of disease on conventional imaging. All patients will undergo a standard
of care, clinical multiparametric endorectal coil MRI in the NCI Molecular Imaging Clinic
within 4 months of the PET scan.
- INCLUSION CRITERIA:
- Age 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.
- Histologically confirmed adenocarcinoma of the prostate
- Patients fit criteria for one of the following categories:
- Cohort 1
--known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage
>T2c) with evidence of disease on standard imaging, OR
- Cohort 2
- nonspecific or no evidence of disease on standard imaging modality AND
biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL
- 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
- Subjects receiving androgen deprivation therapy (ADT)
- 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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