Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
NCT ID: NCT03739684
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2018-11-27
2019-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-DCFPyL Injection
9 mCi (333 MBq) IV injection of 18F-DCFPyL
18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
PET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Interventions
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18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
PET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Progenics Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jessica D Jensen
Role: STUDY_DIRECTOR
Progenics Pharmaceuticals, Inc.
Locations
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City of Hope National Medical Center
Duarte, California, United States
Tower Urology
Los Angeles, California, United States
University of California San Francisco - Helen Diller Cancer Center
San Francisco, California, United States
Stanford
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University - Mallinckrodt Institute of Radiology
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Wisconsin
Madison, Wisconsin, United States
Chu de Quebec - Universite Laval
Québec, , Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PyL 3301
Identifier Type: -
Identifier Source: org_study_id
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