The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence
This is a prospective, multi-institutional, Phase 4 study to assess change in management (CIM) following fluciclovine (18F) imaging in participants with prostate cancer who have a negative or equivocal prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan at the time of any biochemical recurrence (BCR)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
142
fluciclovine (18F) injection, 370 MBq (10 mCi) ± 20%, delivered as an intravenous bolus.
University of California San Diego Health
San Diego, California, United States
NOT_YET_RECRUITINGEmory University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Percentage of participants with any recorded Change In Management following a fluciclovine (18F) PET/CT scan.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
For those participants with a change in management (CIM), percentage of participants with a recorded minor or major CIM following a fluciclovine (18F) PET/CT scan.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
For those participants with a CIM, summary of the CIM groups following a fluciclovine (18F) PET/CT scan.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Participant-level and region-level (prostate bed, pelvic lymph nodes [PLNs], other) detection rates.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Participant-level and region-level (prostate bed, PLNs, other) detection rates stratified by PSA levels.
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with any recorded CIM following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
Percentage of participants with a recorded minor or major CIM following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days
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Washington University
St Louis, Missouri, United States
NOT_YET_RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGUrology Austin
Austin, Texas, United States
NOT_YET_RECRUITINGFor those participants with a CIM, summary of CIM groups following a positive/negative fluciclovine (18F) PET/CT
Time frame: fluciclovine (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 30 calendar days