Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy
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|ClinicalTrials.gov Identifier: NCT04234399|
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : July 16, 2020
Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).
20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA > 0.2 ng/ml.
The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.
The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.
The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).
The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.
|Condition or disease||Intervention/treatment|
|Prostatic Neoplasm||Diagnostic Test: Fluciclovine PET/CT using a digital PET/CT|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) PET/CT Utilizing the High Resolution Digital Philips Vereos Scanner, in Patients With Biochemical Recurrence After Radical Prostatectomy|
|Actual Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2022|
All patients receiving SOC imaging and Axumin PET scans.
Diagnostic Test: Fluciclovine PET/CT using a digital PET/CT
Fluciclovine is a radiotracer that will be used in conjunction with the high resolution digital Vereos PET/CT scanner.
- Detection rate [ Time Frame: Patients will be scheduled for both SOC imaging as well as the Fluciclovine PET within 4 weeks of screening and signing of informed consent. The detection rates between SOC and Fluciclovine scans will be compared. ]Comparison of Fluciclovine digital PET/CT with standard of care imaging. Single time point.
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): NCT04234399
|Contact: Aida Arapovic||802-847-6845||Aida.Arapovic@uvmhealth.org|
|Contact: Dmitriy Akselrod, MD||802-847-2700||Dmitriy.Akselrod@uvmhealth.org|
|United States, Vermont|
|UVM Medical Center||Recruiting|
|Burlington, Vermont, United States, 05401|
|Contact: Aida Arapovic, MS 802-847-6845 Aida.Arapovic@uvmhealth.org|
|Principal Investigator: Dmitriy G Akselrod, MD|