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Fluciclovine F18 for Prostate Cancer
Phase 4
Waitlist Available
Led By Gregory C Ravizzini
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at how well an investigational scan works for measuring response to therapy in patients with metastatic prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolic response by fluciclovine F18 (18F-fluciclovine) positron emission tomography (PET) with standardized uptake values (SUV)
Secondary outcome measures
18F-fluciclovine PET imaging response
Metabolic response by 18F-fluciclovine PET with target to blood pool ratio (TBR)
Sites of progressive disease development
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (fluciclovine F18, PET-CT)Experimental Treatment3 Interventions
Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluciclovine F18
2019
Completed Phase 2
~100
Computed Tomography
2017
Completed Phase 2
~2790
Positron Emission Tomography
2008
Completed Phase 2
~2260
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,915 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,648 Previous Clinical Trials
40,931,742 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Gregory C RavizziniPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
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