This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
221
Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
City of Hope National Medical Center
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Tower Urology
Los Angeles, California, United States
Genesis Research, LLC
San Diego, California, United States
University of Florida
Jacksonville, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Roudebush VA Medical Center
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Washington University School of Medicine
St Louis, Missouri, United States
Coastal Urology Associates
Brick, New Jersey, United States
...and 7 more locations
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
Time frame: 2-22 days post PET CT
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment
The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up. Investigators were instructed to assess any clinically significant change from the revised management plan.
Time frame: 6 months
The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT
Time frame: 1 week
The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population
The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally
Time frame: 1 week
The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time frame: 6 months
The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy
Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI
Time frame: 6 months
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