Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
NCT ID: NCT02981368
Last Updated: 2021-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
385 participants
INTERVENTIONAL
2016-11-30
2018-07-31
Brief Summary
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Cohort B is complete and no longer recruiting subjects.
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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±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 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 Injection
A single dose of 9±1 mCi (333±37 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
2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
Cohort A Only:
* At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA \>20 ng/mL or Gleason score ≥8).
* Scheduled or planned radical prostatectomy with PLND.
Cohort B Only: \[Enrollment is complete; No longer recruiting subjects\]
* Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
* If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.
* Scheduled or planned percutaneous biopsy of at least one amenable lesion.
Exclusion Criteria
2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Cohort A Only:
* Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention
Cohort B Only: \[Enrollment is Complete; No longer recruiting subjects\]
* Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed
* Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.
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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Michael J Morris, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Kenneth J Pienta, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of California at San Francisco (UCSF) - Mt. Zion Hospital
San Francisco, California, United States
Yale University Department of Radiology and Biomedical Imaging
New Haven, Connecticut, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Washington University Mallinckrodt Institute of Radilogy
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec (CHUQ)
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 2301
Identifier Type: -
Identifier Source: org_study_id
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