Trial Outcomes & Findings for An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer (NCT NCT04134208)
NCT ID: NCT04134208
Last Updated: 2025-01-16
Results Overview
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 quantitative data was recently performed for the 2 participants.
TERMINATED
PHASE4
2 participants
Up to 2 years
2025-01-16
Participant Flow
Medical Clinic
No enrolled participants were excluded from the study
Participant milestones
| Measure |
Diagnostic (Fluciclovine F18, PET-CT)
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (Fluciclovine F18, PET-CT)
n=2 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 70.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: No ROC analysis was performed due to the small number of patients. An analysis of the quantitative data was recently performed.
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 quantitative data was recently performed for the 2 participants.
Outcome measures
| Measure |
Diagnostic (Fluciclovine F18, PET-CT) (Participant #1)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
Diagnostic (Fluciclovine F18, PET-CT) (Participant #2)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|---|
|
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"
SUVmax
|
-69.9 percentage of change
|
-50 percentage of change
|
|
Metabolic Response by Fluciclovine F18 (18F-fluciclovine) Positron Emission Tomography (PET) With Standardized Uptake Values (SUV)"
SUVmean
|
-46.3 percentage of change
|
-37.5 percentage of change
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: We compare F-18 fluciclovine PET/CT uptake (SUVmax) in tumors before and after treatment.
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Outcome measures
| Measure |
Diagnostic (Fluciclovine F18, PET-CT) (Participant #1)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
Diagnostic (Fluciclovine F18, PET-CT) (Participant #2)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|---|
|
18F-fluciclovine PET Imaging Response - SUVMax
SUVmax baseline
|
10.8 ng/mL
|
6.6 ng/mL
|
|
18F-fluciclovine PET Imaging Response - SUVMax
SUVmax posttreatment
|
4.1 ng/mL
|
3.3 ng/mL
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: We compare F-18 fluciclovine PET/CT uptake (SUVmean) in tumors before and after treatment.
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.
Outcome measures
| Measure |
Diagnostic (Fluciclovine F18, PET-CT) (Participant #1)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
Diagnostic (Fluciclovine F18, PET-CT) (Participant #2)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|---|
|
18F-fluciclovine PET Imaging Response - SUVMean
SUVmean baseline
|
4.9 mg/mL
|
5.2 mg/mL
|
|
18F-fluciclovine PET Imaging Response - SUVMean
SUVmean posttreatment
|
3.2 mg/mL
|
3.3 mg/mL
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: We compare F-18 fluciclovine PET/CT uptake (Metabolic Tumor Volume) in tumors before and after treatment.
Will evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival defined by Prostate Cancer Working Group 2 criteria.
Outcome measures
| Measure |
Diagnostic (Fluciclovine F18, PET-CT) (Participant #1)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
Diagnostic (Fluciclovine F18, PET-CT) (Participant #2)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|---|
|
18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume
metabolic tumor volume baseline
|
33.6 mL
|
1.2 mL
|
|
18F-fluciclovine PET Imaging Response - Metabolic Tumor Volume
metabolic tumor volume posttreatment
|
0.5 mL
|
0.03 mL
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No newly developed sites of disease were identified (no progressive disease). The primary prostate tumors were biopsied pretreatment, but not re-biopsied post-treatment. In patient#1, a left common iliac lymph node was biopsied prior to treatment, but not re-biopsied after treatment, since this lymph node resolved posttreatment. No analysis for sensitivity and specificity were performed.
Will 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participant #1 underwent baseline imaging, first post-treatment and second post-treatment PET CT scans. Participant #1 second post-treatment data were not measured, since there was no "target." There was no site of disease present on the second posttreatment scan, lesions resolved. The #2 patient did not have any second posttreatment scan.
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.
Outcome measures
| Measure |
Diagnostic (Fluciclovine F18, PET-CT) (Participant #1)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
Diagnostic (Fluciclovine F18, PET-CT) (Participant #2)
n=1 Participants
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.
Computed Tomography: Undergo PET-CT scan
Fluciclovine F18: Given IV
Positron Emission Tomography: Undergo PET-CT scan
|
|---|---|---|
|
Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)
Baseline
|
7.66 target to blood ratio (TBR)
|
4.85 target to blood ratio (TBR)
|
|
Metabolic Response by 18F-fluciclovine PET With Target to Blood Pool Ratio (TBR)
First post-treatment
|
1.19 target to blood ratio (TBR)
|
2.04 target to blood ratio (TBR)
|
Adverse Events
Diagnostic (Fluciclovine F18, PET-CT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gregory Ravizzini
The University of Texas M D Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place