- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495427
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
December 1, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute
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)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / 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
Interventional
Enrollment (Estimated)
60
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Riley Smith
- Phone Number: 813-799-6821
- Email: Riley.Smith@moffitt.org
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- Recruiting
- H. Lee Moffitt Cancer Center and Research Institute
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Principal Investigator:
- Kenneth Gage, M.D., Ph.D.
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Principal Investigator:
- Kosj Yamoah, M.D., Ph.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Previously enrolled to MCC#18523
- Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
- Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
- Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
- Age > 18
Exclusion Criteria:
- No follow up information available post treatment
- Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
- Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
Other Names:
PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Time Frame: Up to 5 years
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To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
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Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kosj Yamoah, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2019
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 5, 2018
First Posted (Actual)
April 12, 2018
Study Record Updates
Last Update Posted (Estimated)
December 4, 2023
Last Update Submitted That Met QC Criteria
December 1, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-19291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on F-DCFPyL Injection
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Centre hospitalier de l'Université de Montréal...RecruitingProstate CancerCanada
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Sidney Kimmel Comprehensive Cancer Center at Johns...Progenics Pharmaceuticals, Inc.Active, not recruitingStudy of PSMA-targeted 18F-DCFPyL PET/CT for the Detection of Clinically Significant Prostate CancerProstate CancerUnited States
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Alessandro D'AgnoloProgenics Pharmaceuticals, Inc.Active, not recruitingNeoplasms | Urogenital Neoplasms | Neoplasms by Site | Genital Neoplasms, Male | Prostatic Neoplasms | Genital Diseases, Male | Prostatic DiseaseUnited States
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)CompletedMetastatic Prostate CancerUnited States
-
Progenics Pharmaceuticals, Inc.CompletedProstate CancerUnited States, Canada
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Sidney Kimmel Comprehensive Cancer Center at Johns...Withdrawn
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