PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
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ClinicalTrials.gov Identifier: NCT03495427 |
Recruitment Status :
Recruiting
First Posted : April 12, 2018
Last Update Posted : December 4, 2023
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Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
Tracking Information | |||||
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First Submitted Date ICMJE | April 5, 2018 | ||||
First Posted Date ICMJE | April 12, 2018 | ||||
Last Update Posted Date | December 4, 2023 | ||||
Actual Study Start Date ICMJE | December 18, 2019 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings [ Time Frame: Up to 5 years ] To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
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Current Secondary Outcome Measures ICMJE |
Rate of Positive PSMA-PET Findings [ Time Frame: Up to 5 years ] 5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.
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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 | PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores | ||||
Official Title ICMJE | The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523) | ||||
Brief Summary | This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment. | ||||
Detailed Description | Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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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: Radioactive Diagnostic Imaging
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
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 | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2024 | ||||
Estimated Primary Completion Date | June 2024 (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 |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03495427 | ||||
Other Study ID Numbers ICMJE | MCC-19291 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Progenics Pharmaceuticals, Inc. | ||||
Investigators ICMJE |
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PRS Account | H. Lee Moffitt Cancer Center and Research Institute | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |