PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | February 2, 2017 |
| End Date: | July 31, 2020 |
| Contact: | Gemma Gliori |
| Email: | ggliori@uwhealth.org |
| Phone: | (608) 262-7269 |
The overall goal of this research is to validate and develop a non-invasive imaging biomarker
of prostate cancer detection, progression, and recurrence. Development of such a biomarker
may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing
for selection of an appropriate risk adaptive therapy.
of prostate cancer detection, progression, and recurrence. Development of such a biomarker
may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing
for selection of an appropriate risk adaptive therapy.
The investigators will evaluate a novel second-generation low-molecular-weight prostate
specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,
for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very
high tumor-to-background and tumor specific uptake which may allow for a more sensitive and
accurate method for detection of early tumor recurrence and metastatic disease as compared to
current PET radiotracers and current standard-of-care imaging including 99mTc-methylene
diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and
magnetic resonance imaging (MRI). The investigators propose to evaluate this PET agent for
three different prostate cancer clinical scenarios: (1) detection of clinically significant
high-grade prostate cancer and initial staging, (2) detection of sites of recurrence in the
setting of biochemical recurrence after definitive prostatectomy, and (3) detection of
advanced androgen-resistant metastatic prostate cancer.
specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL,
for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very
high tumor-to-background and tumor specific uptake which may allow for a more sensitive and
accurate method for detection of early tumor recurrence and metastatic disease as compared to
current PET radiotracers and current standard-of-care imaging including 99mTc-methylene
diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and
magnetic resonance imaging (MRI). The investigators propose to evaluate this PET agent for
three different prostate cancer clinical scenarios: (1) detection of clinically significant
high-grade prostate cancer and initial staging, (2) detection of sites of recurrence in the
setting of biochemical recurrence after definitive prostatectomy, and (3) detection of
advanced androgen-resistant metastatic prostate cancer.
Inclusion Criteria:
- Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for
sub-study #1)
- Prostate biopsy histology grade ≥ Gleason 6, positive biopsy >2 cores.
- PSA > 0.2 ng/mL for Sub-study #2 or >1.0 ng/mL for Sub-study #3
- Patients considered as candidates for and medically fit to undergo prostatectomy
- At least 7 days after most recent prostate biopsy
- Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI,
ultrasound or other PET modalities (Sub-study #3 only)
Exclusion Criteria:
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Hormone deprivation therapy
- Investigational therapy for prostate cancer
- Unable to lie flat during or tolerate PET/CT
- Prior history of any other malignancy within the last 2 years, other than skin basal
cell or cutaneous superficial squamous cell carcinoma that has not metastasized and
superficial bladder cancer.
- No prostatectomy scheduled more than 12 hours post imaging
- Serum creatinine > 2 time the upper limit of normal
- Total bilirubin > 3 times the upper limit of normal
- Liver Transaminases > 5 times the upper limit of normal
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Steve Y Cho, MD
Phone: 608-262-7269
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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