Prostate Cancers
Conditions
Brief summary
The purpose of this research project is to test if a compound (chemical substance) has a natural tendency to go to prostate cancer. This compound has a small amount of radioactivity attached to it and is called a radiotracer. The name of the radiotracer is FACBC and can be detected on a special imaging device called a PET scanner (positron emission tomography). The radiotracer is treated in the body much like an amino acid which is a nutrient required for normal functioning. Tumors also use these nutrients. Earlier studies have shown that this radiotracer may be able to detect prostate cancer. The investigators will perform a study with 20 patients in whom they know have prostate cancer after a biopsy and who are scheduled for an operation in which the prostate is removed and the nearby lymph nodes are examined. This operation is called prostatectomy. The investigators think that this radiotracer can help us determine where exactly the prostate cancer is present in the prostate or if it has spread. This information may be useful in the future to help with other non-surgical therapy such as radiation beam therapy. The investigators will compare the results of the FACBC PET scan to the results of the pathology analysis of the removed prostate. In this way the investigators can determine how good a test FACBC PET is for finding out where and if prostate cancer is located in the prostate or nearby lymph nodes. The investigators will also do more advanced analysis on the biopsy samples to see if they can tell why FACBC goes into prostate cancer cells. This radiotracer has been tested in over 100 human subjects without incident. It has also been chosen by the National Institutes of Health (NIH) as a promising radiotracer. The NIH is funding this study.
Interventions
DRUGanti [18F]FACBC
Anti\[18F\]FACBC (10mci) will be given intravenously over 1-2 minutes prior to obtaining PET-CT images At 4 minutes, 10 consecutive/4minutes images will be obtained of the pelvis to include the prostate.
Sponsors
David M. Schuster, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be 18 years of age or older. * Patients will be scheduled for prostatectomy based on a diagnosis of primary prostate cancer. * Ability to lie still for PET scanning * Patients must be able to provide written informed consent.
Exclusion criteria
* Age less than 18 * Inability to lie still for PET scanning * Cannot provide written informed consent. * Less than 4 weeks since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | At 4, 16, 28 and 40 minutes post-injection of FACBC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean SUVmax of Low Versus High Gleason Groups | 4 minutes,16 minutes,28 minutes and 40 minutes | To determine id radiotracer uptake correlates with gleason score |
Countries
United States
Participant flow
Recruitment details
Recruitment period: 5/2008-3/2011. Subjects were referred from physician's offices
Participants by arm
| Arm | Count |
|---|---|
| Radiotracer \[18F\] FACBC 10mci injected intravenously prior to PET scan | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Radiotracer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 60.8 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Diagnostic Performance Per Sextant at 4mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Accuracy (n = 118, 120, 120, 120) | 66.1 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant at 4mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Specificity (n = 39, 39, 40, 40) | 18.0 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant at 4mins Post Injection | 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 |
| Diagnostic Performance Per Sextant at 4mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | NPV (n = 15, 27, 35, 32) | 46.7 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant at 4mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | PPV (n = 103, 93, 85, 88) | 68.9 Percentage of Sextants | — |
| Diagnostic Performance Per sextant16mins Post Injetion | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | NPV (n = 15, 27, 35, 32) | 51.9 Percentage of Sextants | — |
| Diagnostic Performance Per sextant16mins Post Injetion | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Accuracy (n = 118, 120, 120, 120) | 68.3 Percentage of Sextants | — |
| Diagnostic Performance Per sextant16mins Post Injetion | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | PPV (n = 103, 93, 85, 88) | 73.1 Percentage of Sextants | — |
| Diagnostic Performance Per sextant16mins Post Injetion | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Specificity (n = 39, 39, 40, 40) | 35.9 Percentage of Sextants | — |
| Diagnostic Performance Per sextant16mins Post Injetion | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Sensitivity (n=79, 81, 80, 80) | 84.0 Percentage of Sextants | 95% Confidence Interval 1.6 |
| Diagnostic Performance Per Sextant 28mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Specificity (n = 39, 39, 40, 40) | 50.0 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 28mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | NPV (n = 15, 27, 35, 32) | 57.1 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 28mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Sensitivity (n=79, 81, 80, 80) | 81.3 Percentage of Sextants | 95% Confidence Interval 1.3 |
| Diagnostic Performance Per Sextant 28mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | PPV (n = 103, 93, 85, 88) | 76.5 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 28mins Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Accuracy (n = 118, 120, 120, 120) | 70.8 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Accuracy (n = 118, 120, 120, 120) | 65.0 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Sensitivity (n=79, 81, 80, 80) | 78.8 Percentage of Sextants | 95% Confidence Interval 1 |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | PPV (n = 103, 93, 85, 88) | 71.6 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | Specificity (n = 39, 39, 40, 40) | 37.5 Percentage of Sextants | — |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis | NPV (n = 15, 27, 35, 32) | 46.9 Percentage of Sextants | — |
Secondary
Mean SUVmax of Low Versus High Gleason Groups
To determine id radiotracer uptake correlates with gleason score
Time frame: 4 minutes,16 minutes,28 minutes and 40 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic Performance Per Sextant at 4mins Post Injection | Mean SUVmax of Low Versus High Gleason Groups | Low gleason group | 4.4 Mean SUV max | Standard Deviation 2.1 |
| Diagnostic Performance Per Sextant at 4mins Post Injection | Mean SUVmax of Low Versus High Gleason Groups | High gleason group | 5.9 Mean SUV max | Standard Deviation 2.8 |
| Diagnostic Performance Per sextant16mins Post Injetion | Mean SUVmax of Low Versus High Gleason Groups | High gleason group | 5.2 Mean SUV max | Standard Deviation 1.7 |
| Diagnostic Performance Per sextant16mins Post Injetion | Mean SUVmax of Low Versus High Gleason Groups | Low gleason group | 3.8 Mean SUV max | Standard Deviation 1.1 |
| Diagnostic Performance Per Sextant 28mins Post Injection | Mean SUVmax of Low Versus High Gleason Groups | High gleason group | 4.7 Mean SUV max | Standard Deviation 1.3 |
| Diagnostic Performance Per Sextant 28mins Post Injection | Mean SUVmax of Low Versus High Gleason Groups | Low gleason group | 3.5 Mean SUV max | Standard Deviation 1 |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Mean SUVmax of Low Versus High Gleason Groups | Low gleason group | 3.3 Mean SUV max | Standard Deviation 0.9 |
| Diagnostic Performance Per Sextant 40minutes Post Injection | Mean SUVmax of Low Versus High Gleason Groups | High gleason group | 3.3 Mean SUV max | Standard Deviation 0.9 |