18 and older, male only, with Metastatic Prostate Carcinoma or Stage IVB Prostate Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"Primary· Up to 2 years
Will evaluate metabolic response by 18F-fluciclovine PET qualitatively and semi-quantitatively with SUV and correlate the findings with size changes as defined by conventional imaging prostate specific antigen (PSA) response. The percentage of change in the 18F-fluciclovine maximum standardized uptake value (SUVmax) after therapy will be calculated as follows (\[pretreatment corrected SUVmax - posttreatment corrected SUVmax\]/pretreatment corrected SUVmax) x 100. Similar calculations will be performed for mean SUV, metabolic tumor volume, and total volume activity.
An analysis of the quantita
18F-fluciclovine PET Imaging Response - SUVMaxSecondary· Up to 2 years
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
18F-fluciclovine PET Imaging Response - SUVMeanSecondary· Up to 2 years
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria. SUVmean represents the average SUV value across a defined region of interest (ROI) in the tumor. The Measure Type is a number, that is dimensionless, because it is the average ratio of tissue activity concentration to the injected dose normalized by the patient's weight.
18F-fluciclovine PET Imaging Response - Metabolic Tumor VolumeSecondary· Up to 2 years
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)Secondary· Up to 2 years
Will evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with TBR and correlate the findings with size changes as defined by conventional imaging and PSA response.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 16 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04134208.