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 : January 26, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrent Prostate Cancer||Drug: F-DCFPyL Injection Diagnostic Test: PSMA PET||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||December 18, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2024|
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.
Drug: F-DCFPyL Injection
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
Other Name: Imaging agent
Diagnostic Test: PSMA PET
PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495427
|Contact: Angelina Finkemail@example.com|
|Contact: Angelina Fink||Fax: 813-449-6672|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Principal Investigator: Kosj Yamoah, M.D., Ph.D.|
|Principal Investigator: Kenneth Gage, M.D., Ph.D.|
|Principal Investigator:||Kosj Yamoah, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|
|Responsible Party:||H. Lee Moffitt Cancer Center and Research Institute|
|Other Study ID Numbers:||
|First Posted:||April 12, 2018 Key Record Dates|
|Last Update Posted:||January 26, 2023|
|Last Verified:||January 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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