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18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)
This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18F-fluciclovine is a radioactive substance that is used in this study with PET-CT imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.
PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response. SECONDARY OBJECTIVES: I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement. II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 \[PCWG2\] criteria). III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response. OUTLINE: Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
September 19, 2019
Primary Completion Date
June 28, 2022
Completion Date
June 28, 2022
Last Updated
January 16, 2025
2
ACTUAL participants
Computed Tomography
PROCEDURE
Fluciclovine F18
DRUG
Positron Emission Tomography
PROCEDURE
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT04550494
NCT06305598
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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