Trial Outcomes & Findings for FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer (NCT NCT00917865)

Results Overview

Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor. Sensitivity: Proportion of people with a disease who have a positive test result Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted. Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted Accuracy: Ability of the test to differentiate between disease and non-disease. Note: 'n=' is the denominator used to compute each parameter.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

At 4, 16, 28 and 40 minutes post-injection of FACBC

Results posted on

2014-01-07

Participant Flow

Recruitment period: 5/2008-3/2011. Subjects were referred from physician's offices

Participant milestones

Participant milestones
Measure	Radiotracer \[18F\] FACBC 10mci injected intravenously prior to PET scan
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FACBC Positron Emission Tomography/Computed Tomography(PET/CT) Used in the Diagnosis of Primary Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiotracer n=11 Participants \[18F\] FACBC 10mci injected intravenously prior to PET scan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: At 4, 16, 28 and 40 minutes post-injection of FACBC

Population: The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter.

Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor. Sensitivity: Proportion of people with a disease who have a positive test result Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted. Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted Accuracy: Ability of the test to differentiate between disease and non-disease. Note: 'n=' is the denominator used to compute each parameter.

Outcome measures

Outcome measures
Measure	Diagnostic Performance Per Sextant at 4mins Post Injection n=118 Sextants Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.	Diagnostic Performance Per sextant16mins Post Injetion n=120 Sextants At this time point, the 120 sextants analysed were categorized as followed: 68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative	Diagnostic Performance Per Sextant 28mins Post Injection n=120 Sextants At this time point, the 120 sextants analysed were categorized as followed: 65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative	Diagnostic Performance Per Sextant 40minutes Post Injection n=120 Sextants At this time point, the 120 sextants analysed were categorized as followed: 63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis Sensitivity (n=79, 81, 80, 80)	89.9 Percentage of Sextants 95% Confidence Interval 2.6 • Interval 80.5 to 95.2	84.0 Percentage of Sextants 95% Confidence Interval 1.6 • Interval 73.8 to 90.9	81.3 Percentage of Sextants 95% Confidence Interval 1.3 • Interval 70.6 to 88.8	78.8 Percentage of Sextants 95% Confidence Interval 1.0 • Interval 67.9 to 86.8
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis Specificity (n = 39, 39, 40, 40)	18.0 Percentage of Sextants Interval 8.1 to 34.1	35.9 Percentage of Sextants Interval 21.7 to 52.9	50.0 Percentage of Sextants Interval 34.1 to 65.9	37.5 Percentage of Sextants Interval 23.2 to 54.2
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis PPV (n = 103, 93, 85, 88)	68.9 Percentage of Sextants Interval 59.0 to 77.5	73.1 Percentage of Sextants Interval 62.8 to 81.5	76.5 Percentage of Sextants Interval 65.8 to 84.7	71.6 Percentage of Sextants Interval 60.8 to 80.5
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis NPV (n = 15, 27, 35, 32)	46.7 Percentage of Sextants Interval 22.3 to 72.6	51.9 Percentage of Sextants Interval 32.4 to 70.9	57.1 Percentage of Sextants Interval 39.5 to 73.2	46.9 Percentage of Sextants Interval 29.5 to 65.0
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis Accuracy (n = 118, 120, 120, 120)	66.1 Percentage of Sextants Interval 56.7 to 74.4	68.3 Percentage of Sextants Interval 59.1 to 76.4	70.8 Percentage of Sextants Interval 61.7 to 78.6	65.0 Percentage of Sextants Interval 55.7 to 73.3

SECONDARY outcome

Timeframe: 4 minutes,16 minutes,28 minutes and 40 minutes

To determine id radiotracer uptake correlates with gleason score

Outcome measures

Outcome measures
Measure	Diagnostic Performance Per Sextant at 4mins Post Injection n=10 Participants Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.	Diagnostic Performance Per sextant16mins Post Injetion n=10 Participants At this time point, the 120 sextants analysed were categorized as followed: 68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative	Diagnostic Performance Per Sextant 28mins Post Injection n=10 Participants At this time point, the 120 sextants analysed were categorized as followed: 65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative	Diagnostic Performance Per Sextant 40minutes Post Injection n=10 Participants At this time point, the 120 sextants analysed were categorized as followed: 63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative
Mean SUVmax of Low Versus High Gleason Groups Low gleason group	4.4 Mean SUV max Standard Deviation 2.1	3.8 Mean SUV max Standard Deviation 1.1	3.5 Mean SUV max Standard Deviation 1.0	3.3 Mean SUV max Standard Deviation 0.9
Mean SUVmax of Low Versus High Gleason Groups High gleason group	5.9 Mean SUV max Standard Deviation 2.8	5.2 Mean SUV max Standard Deviation 1.7	4.7 Mean SUV max Standard Deviation 1.3	3.3 Mean SUV max Standard Deviation 0.9

Adverse Events

Radiotracer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Schuster, MD

Emory University

Phone: 404-712-4859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place