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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA129356-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACBC PET-CT and ProstaScint CT | Other | Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACBC | Drug | Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
|
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STUDY NOW CLOSED for recruitment
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Schuster, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24144687 | Background | Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19. | |
| 21493787 |
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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.
The study was completed November 28,2007 through July 10, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants completed both the FACBC PET-CT and the ProstaScint CT.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 91 participants had sufficient data to determine disease presence or absence in the prostate bed. | Posted | Number | participants | Up to 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FACBC PET-CT and ProstaScint CT | All participants who received scans, including repeat scans, were monitored for adverse events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David M. Schuster, MD | Emory University | 404-712-4859 | dschust@emory.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
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|
| ProstaScinct | Other | 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. |
|
|
| Up to 5 years |
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
| Up to 5 years |
| Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
| Up to 5 years |
| Up to 5 years |
| Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
| Up to 5 years |
| Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14. |
| 21825855 | Background | Amzat R, Taleghani P, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Lewis MM, Faurot M, Bellamy LM, Goodman MM, Schuster DM. Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clin Nucl Med. 2011 Sep;36(9):800-2. doi: 10.1097/RLU.0b013e318219b47e. |
| 19387202 | Background | Jani AB, Fox TH, Whitaker D, Schuster DM. Case study of anti-1-amino-3-F-18 fluorocyclobutane-1-carboxylic acid (anti-[F-18] FACBC) to guide prostate cancer radiotherapy target design. Clin Nucl Med. 2009 May;34(5):279-84. doi: 10.1097/RLU.0b013e31819e51e3. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| 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. | 91 participants had sufficient data to determine disease presence or absence in the prostate bed. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | 91 participants had sufficient data to determine disease presence or absence in the prostate bed. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | 91 participants had sufficient data to determine disease presence or absence in the prostate bed. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations. | Posted | Number | participants | Up to 5 years |
|
|
|
| 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. | There was sufficient data for 70 participants to determine disease presence or absence at extraprostatic locations. | Posted | Number | participants | Up to 5 years |
|
|
|
| Primary | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
| Participants with a definitive consensus for the presence or absence of extraprostatic disease. | Posted | Number | 95% Confidence Interval | percentage of true tests | Up to 5 years |
|
|
|
| Primary | Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
| Participants with a definitive consensus on the presence or absence of prostatic/bed disease. | Posted | Number | 95% Confidence Interval | percentage of true tests | Up to 5 years |
|
|
|
| Secondary | Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed |
| Participants with a definitive consensus on the presence or absence of prostatic/bed disease. | Posted | Number | 95% Confidence Interval | percentage of true tests | Up to 5 years |
|
|
|
| Secondary | Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma |
| Participants with a definitive consensus for the presence or absence of extraprostatic disease. | Posted | Number | 95% Confidence Interval | percentage of true tests | Up to 5 years |
|
|
|
| 0 |
| 115 |
| 0 |
| 115 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
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| Title | Measurements |
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| % Negative Predictive Value |
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| Title | Measurements |
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| % Positive Predictive Value |
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| % Negative Predictive Value |
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| Title | Measurements |
|---|---|
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| % Positive Predictive Value |
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| % Negative Predictive Value |
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