Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (CONDOR)
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ClinicalTrials.gov Identifier: NCT03739684 |
Recruitment Status :
Completed
First Posted : November 14, 2018
Last Update Posted : September 25, 2020
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Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | November 9, 2018 | ||||||
First Posted Date ICMJE | November 14, 2018 | ||||||
Last Update Posted Date | September 25, 2020 | ||||||
Actual Study Start Date ICMJE | November 27, 2018 | ||||||
Actual Primary Completion Date | August 29, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Correct Localization Rate (CLR), defined as percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. [ Time Frame: Within 60 days following PyL PET/CT imaging. ] Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Percentage of subjects with a change in intended prostate cancer treatment plans due to 18F-DCFPyL PET/CT imaging results. [ Time Frame: Pre-PyL imaging and within 60 days following PyL imaging. ] The change in intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after PyL PET/CT imaging.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: 18F-DCFPyL Injection
9 mCi (333 MBq) IV injection of 18F-DCFPyL
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
208 | ||||||
Original Estimated Enrollment ICMJE |
200 | ||||||
Actual Study Completion Date ICMJE | August 29, 2019 | ||||||
Actual Primary Completion Date | August 29, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03739684 | ||||||
Other Study ID Numbers ICMJE | PyL 3301 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Progenics Pharmaceuticals, Inc. | ||||||
Study Sponsor ICMJE | Progenics Pharmaceuticals, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Progenics Pharmaceuticals, Inc. | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |