Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:November 27, 2018
End Date:January 2020
Contact:Khushboo Shah
Email:kbshah@progenics.com
Phone:646-975-2557

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A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging
in patients with suspected recurrence of prostate cancer who have negative or equivocal
findings on conventional imaging.


Inclusion Criteria:

- Male >/= 18 years of age

- Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with
subsequent definitive therapy

- Suspected recurrence of prostate cancer based on rising PSA after definitive therapy
on the basis of:

1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a
confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or

2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that
is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic
Radiology and Oncology [ASTRO]-Phoenix)

- Negative or equivocal findings for prostate cancer on conventional imaging performed
as part of standard of care workup within 60 days prior to Day 1

- Life expectancy ≥6 months as determined by the investigator

- Able and willing to provide informed consent and comply with protocol requirements

Exclusion Criteria:

- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
five (5) physical half-lives prior to Day 1

- Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH
agonist or antagonist) for prostate cancer

- Treatment with ADT in the past 3 months of Day 1

- Receipt of investigational therapy for prostate cancer within 60 days of Day 1

- Subjects with any medical condition or other circumstances that, in the opinion of the
investigator, compromise the safety or compliance of the subject to produce reliable
data or completing the study
We found this trial at
15
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Los Angeles, California 90048
Principal Investigator: David Josephson, MD
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Michael Gorin, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Janet Pollard, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Stanford, California 94304
Principal Investigator: Andrei Iagaru, MD
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Morand Piert, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Mark Preston, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Jeffrey Wong, MD
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Steve Cho, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Lawrence Saperstein, MD
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Michael Morris, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Austin Pantel, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Quebec,
Principal Investigator: Frederic Pouliot, MD
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Saint Louis, Missouri 63110
Principal Investigator: Barry Siegel, MD
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San Francisco, California 94143
Principal Investigator: Peter Carroll, MD
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Tampa, Florida 33612
Principal Investigator: Kenneth Gage, MD
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