Trial Outcomes & Findings for Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC) (NCT NCT02443571)
NCT ID: NCT02443571
Last Updated: 2018-12-19
Results Overview
Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Recruitment status
COMPLETED
Target enrollment
714 participants
Primary outcome timeframe
Up to 35 days post Fluciclovine 18F
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Recurrent Prostate Cancer
Recurrent Prostate Cancer
|
Primary Prostate Cancer
Primary Prostate Cancer
|
Other Cancers
Other Cancers
|
|---|---|---|---|
|
Overall Study
STARTED
|
596
|
95
|
23
|
|
Overall Study
COMPLETED
|
596
|
95
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Observational Study Investigating Fluciclovine (18F) (FACBC)
Baseline characteristics by cohort
| Measure |
Recurrent Prostate Cancer
n=596 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
n=95 Participants
Primary Prostate Cancer
|
Other Cancers
n=23 Participants
Other Cancers
|
Total
n=714 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 Years
n=5 Participants
|
65 Years
n=7 Participants
|
61 Years
n=5 Participants
|
66 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
596 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
698 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
186 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
382 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
480 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
137 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Region of Enrollment
Norway
|
371 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
88 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 35 days post Fluciclovine 18FPopulation: Patients who have received at least one dose of Fluciclovine 18F
Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Outcome measures
| Measure |
Recurrent Prostate Cancer
n=596 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
n=95 Participants
Primary Prostate Cancer
|
Other Cancers
n=23 Participants
Other Cancers
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Treatment Emergent Adverse Events
|
32 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Treatment Emergent Serious Adverse Events
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post Fluciclovine 18FPopulation: Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings. When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique.
Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Outcome measures
| Measure |
Recurrent Prostate Cancer
n=143 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
Primary Prostate Cancer
|
Other Cancers
Other Cancers
|
|---|---|---|---|
|
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Subject PPV
|
82.4 Percentage of participants
Interval 74.3 to 88.7
|
—
|
—
|
|
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Extraprostatic Region PPV
|
92.3 Percentage of participants
Interval 79.1 to 98.4
|
—
|
—
|
|
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
Prostate & Prostate Bed Region PPV
|
71.8 Percentage of participants
Interval 62.1 to 80.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 year post Fluciclovine 18FPositive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Outcome measures
| Measure |
Recurrent Prostate Cancer
n=61 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
Primary Prostate Cancer
|
Other Cancers
Other Cancers
|
|---|---|---|---|
|
Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
|
100 Percentage of participants
Interval 93.7 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post Fluciclovine 18FDetection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.
Outcome measures
| Measure |
Recurrent Prostate Cancer
n=125 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
Primary Prostate Cancer
|
Other Cancers
Other Cancers
|
|---|---|---|---|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Detection Rate
|
82.4 Percentages
Interval 74.6 to 88.6
|
—
|
—
|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Sensitivity
|
94.7 Percentages
Interval 88.0 to 98.3
|
—
|
—
|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Specificity
|
54.8 Percentages
Interval 36.0 to 72.7
|
—
|
—
|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer
Negative Predictive Value
|
77.3 Percentages
Interval 54.6 to 92.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post Fluciclovine 18FDetection rate is the percentage of participants with positive finding in Fluciclovine 18F scan. Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan. Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan. Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy.
Outcome measures
| Measure |
Recurrent Prostate Cancer
n=61 Participants
Recurrent Prostate Cancer
|
Primary Prostate Cancer
Primary Prostate Cancer
|
Other Cancers
Other Cancers
|
|---|---|---|---|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Detection Rate
|
93.4 Percentage of participants
Interval 84.1 to 98.2
|
—
|
—
|
|
Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
Sensitivity
|
93.4 Percentage of participants
Interval 84.1 to 98.2
|
—
|
—
|
Adverse Events
18F-Fluciclovine PET
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
18F-Fluciclovine PET
n=714 participants at risk
18F-Fluciclovine PET
|
|---|---|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.14%
1/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
|
Injury, poisoning and procedural complications
Post Procedural Pulmonary Embolism
|
0.14%
1/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
|
Vascular disorders
Hypertension
|
0.14%
1/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
|
Investigations
Blood Pressure Decreased
|
0.14%
1/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
|
Investigations
Haemoglobin decreased
|
0.14%
1/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
Other adverse events
| Measure |
18F-Fluciclovine PET
n=714 participants at risk
18F-Fluciclovine PET
|
|---|---|
|
General disorders
Injection site extravasation
|
1.3%
9/714 • All Treatment Emergent Adverse Events (TEAEs) occurring up to 35 days after each 18F-fluciclovine administration, and for all TEAEs occurring between two consecutive administrations of 18F and up to 35 days after the last 18F administration.
|
Additional Information
Chief Medical Officer
Blue Earth Diagnostics Ltd.
Phone: +44 (0) 1865 784 186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place