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 : Suspended (Compounding facility to submit quality update before they can manufacture 18F-DCFPyL)
First Posted : April 12, 2018
Last Update Posted : May 22, 2020
|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 :||October 17, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
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.
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
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Kosj Yamoah, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|