PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
Status
RECRUITING
Phase
PHASE2, PHASE3
Age
≥ 18 Years
Enrollments
60Conditions
Prostate Cancer, Recurrent Prostate CancerDrugs
F-DCFPyL InjectionSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Kosj Yamoah, M.D., Ph.D.
Principal Investigator
- Kosj Yamoah, M.D., Ph.D.
Eligibility Criteria
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
Outcome Measures
Primary Outcome Measures
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Secondary Outcome Measures
Rate of Positive PSMA-PET Findings
Timeline
Last Updated
November 8, 2024Start Date
April 12, 2018Today
February 5, 2025Completion Date ( Estimated )
May 1, 2029
Sponsors of this trial
Lead Sponsor
H. Lee Moffitt Cancer Center and Research InstituteCollaborating Sponsors
Progenics Pharmaceuticals, Inc.
RECRUITING 
21 - 64 Years