Prostate Cancer
Conditions
Brief summary
Hypothesis:Anti-\[18F\]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called \[18\]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called \[18\]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called \[18\]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-\[18F\]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the \[18\]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
Interventions
DRUGFACBC
Anti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
OTHERProstaScinct
ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
Sponsors
National Cancer Institute (NCI)
David M. Schuster, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
STUDY NOW CLOSED for recruitment Inclusion Criteria: * Patients must be 18 years of age or older. * Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease. * In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called PSA bump. * Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy. * Ability to lie still for PET scanning * Patients must be able to provide written informed consent.
Exclusion criteria
* Age less than 18. * Greater than T3 disease in past * Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy. * Does not meet above criteria of suspicious PSA elevation * Inability to lie still for PET scanning * Cannot provide written informed consent. * Bone scan findings characteristic for metastatic prostate carcinoma * Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | Up to 5 years | 1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed |
| Number of Participants With False Negative Scans Outside the Prostate Bed | Up to 5 years | Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up. |
| Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | Up to 5 years | 1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\] 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed |
| Number of Participants With True Positive Scans Within the Prostate Bed | Up to 5 years | Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up. |
| Number of Participants With False Positive Scans Within the Prostate Bed | Up to 5 years | Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up. |
| Number of Participants With True Negative Scans Within the Prostate Bed | Up to 5 years | Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up. |
| Number of Participants With False Negative Scans Within the Prostate Bed | Up to 5 years | Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up. |
| Number of Participants With True Positive Scans Outside the Prostate Bed | Up to 5 years | Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up. |
| Number of Participants With True Negative Scans Outside the Prostate Bed | Up to 5 years | Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up. |
| Number of Participants With False Positive Scans Outside the Prostate Bed | Up to 5 years | Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | Up to 5 years | 1. Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\] 2. Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed |
| Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | Up to 5 years | 1. Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed |
Countries
United States
Participant flow
Recruitment details
The study was completed November 28,2007 through July 10, 2012.
Pre-assignment details
Of the 128 participants consented, 93 participants met the criteria to receive the ProstaScint (In-capromab pendetide) and the FACBC (anti-3-\[18F\]) scans. 115 participants had FACBC scans, with 13 receiving repeat scans. Therefore, excluding 13 participants. 93 participants had one FACBC scan and one ProstaScint scan and did not have repeat scans.
Participants by arm
| Arm | Count |
|---|---|
| FACBC PET-CT and ProstaScint CT Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT. | 93 |
| Total | 93 |
Baseline characteristics
| Characteristic | FACBC PET-CT and ProstaScint CT |
|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 93 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 115 |
| serious Total, serious adverse events | 0 / 115 |
Outcome results
Primary
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\] 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time frame: Up to 5 years
Population: Participants with a definitive consensus for the presence or absence of extraprostatic disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Sensitivity | 55.0 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Specificity | 96.7 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Accuracy | 72.9 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Positive Predictive Value | 95.7 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Negative Predictive Value | 61.7 percentage of true tests |
Primary
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time frame: Up to 5 years
Population: Participants with a definitive consensus on the presence or absence of prostatic/bed disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Sensitivity | 90.2 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Specificity | 40.0 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Accuracy | 73.6 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Positive Predictive Value | 75.3 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Negative Predictive Value | 66.7 percentage of true tests |
Primary
Number of Participants With False Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time frame: Up to 5 years
Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Negative Scans Outside the Prostate Bed | FACBC PET-CT | 18 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Negative Scans Outside the Prostate Bed | ProstaScint CT | 36 participants |
Primary
Number of Participants With False Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Time frame: Up to 5 years
Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Negative Scans Within the Prostate Bed | FACBC PET-CT | 6 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Negative Scans Within the Prostate Bed | ProstaScint CT | 20 participants |
Primary
Number of Participants With False Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time frame: Up to 5 years
Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Positive Scans Outside the Prostate Bed | FACBC PET-CT | 1 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Positive Scans Outside the Prostate Bed | ProstaScint CT | 4 participants |
Primary
Number of Participants With False Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time frame: Up to 5 years
Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Positive Scans Within the Prostate Bed | FACBC PET-CT | 18 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With False Positive Scans Within the Prostate Bed | ProstaScint CT | 13 participants |
Primary
Number of Participants With True Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time frame: Up to 5 years
Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Negative Scans Outside the Prostate Bed | FACBC PET-CT | 29 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Negative Scans Outside the Prostate Bed | ProstaScint CT | 26 participants |
Primary
Number of Participants With True Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time frame: Up to 5 years
Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Negative Scans Within the Prostate Bed | FACBC PET-CT | 12 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Negative Scans Within the Prostate Bed | ProstaScint CT | 17 participants |
Primary
Number of Participants With True Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time frame: Up to 5 years
Population: There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Positive Scans Outside the Prostate Bed | FACBC PET-CT | 22 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Positive Scans Outside the Prostate Bed | ProstaScint CT | 4 participants |
Primary
Number of Participants With True Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Time frame: Up to 5 years
Population: 91 participants had sufficient data to determine disease presence or absence in the prostate bed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Positive Scans Within the Prostate Bed | FACBC PET-CT | 55 participants |
| FACBC PET-CT and ProstaScint CT | Number of Participants With True Positive Scans Within the Prostate Bed | ProstaScint CT | 41 participants |
Secondary
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
1. Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\] 2. Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time frame: Up to 5 years
Population: Participants with a definitive consensus for the presence or absence of extraprostatic disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Sensitivity | 10.0 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Specificity | 86.7 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Accuracy | 42.9 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Positive Predictive Value | 50.0 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma | % Negative Predictive Value | 41.9 percentage of true tests |
Secondary
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
1. Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time frame: Up to 5 years
Population: Participants with a definitive consensus on the presence or absence of prostatic/bed disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Sensitivity | 67.2 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Specificity | 56.7 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Accuracy | 63.7 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Positive Predictive Value | 75.9 percentage of true tests |
| FACBC PET-CT and ProstaScint CT | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed | % Negative Predictive Value | 45.9 percentage of true tests |