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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
| Nihon Medi-Physics Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess if using anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will be useful in determining if participants are responding to chemotherapy treatment. Investigators will enroll participants whose cancer has been treated with hormone therapy and now the cancer is not responding to the treatment (castration -resistant), and so therefore will be started on chemotherapy. Investigators aim to enroll thirty participants in this study.
The goal of the investigation is to examine therapeutic monitoring of chemotherapy in castrate resistant prostate carcinoma with anti-3-[18F]FACBC in prostate carcinoma to determine if anti-3-[18F]FACBC amino acid imaging can serve as an accurate and efficient imaging biomarker.
Investigators will perform a baseline anti-3-[18F]FACBC PET-CT of the whole body. All participants will also undergo conventional staging including 99mTc methylene diphosphonate (MDP) bone scanning and computed tomography scan (CT) or magnetic resonance imaging (MR) of the abdomen and pelvis which are standard of care at the enrolling institution. This study will not interfere with standard patient evaluation or delay therapy.
All 30 participants will receive chemotherapy every 3 weeks for 6 cycles. Participants will undergo a repeat anti-3-[18F]FACBC PET-CT after 1 and 6 cycles and also repeat conventional imaging including bone scanning CT or MR of the abdomen and pelvis after 6 cycles. At the end of the study, the study team will then record the response (or lack thereof) on anti-3-[18F]FACBC PET-CT and correlate that response with response per standard clinical criteria including bone scan uptake for skeletal lesions, CT or MR for soft tissue and skeletal lesions, prostate-specific antigen (PSA) progression or regression, and other clinical parameters such as declining performance status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACBC | Experimental | Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACBC PET-CT | Drug | Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change Assessed by FACBC PET Scan | Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells. | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
| Prostate Specific Antigen Level | Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer. | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
| Number of Participants Responding to Treatment Assessed by MRI | Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:
| Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths | The number of deaths that have occurred was assessed at the end of study. | End of Study (up to 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David 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. |
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Study participants were recruited from patients receiving services at Emory University Hospital in Atlanta, Georgia. Participant enrollment began in July 2016, follow up for the primary outcome measures was complete by December 1, 2018 and follow up for the secondary outcome measure was completed on September 30, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | FACBC PET-CT | Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC) radiotracer intravenously prior to positron emission tomography (PET) scan. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FACBC PET-CT | Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Change Assessed by FACBC PET Scan | Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells. | This analysis includes participants completing the study visits used in each change from baseline determination. | Posted | Mean | Standard Deviation | percent change of SUVmax | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
|
Information about adverse events that were potentially related to the radiotracer used for FACBC PET-CT scan was collected from the time of giving consent to participate in the study through the post-cycle 6 visit, approximately 17 weeks.
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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 | Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Schuster, MD | Emory University | (404) 712-4859 | dschust@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2018 | Nov 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| D000091642 | Urogenital Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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|
| MRI, CT, or Bone Scan | Other | Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings. |
|
| Number of Participants Responding to Treatment Assessed by CT Scan |
A CT will be used to assess response to treatment. Treatment response will be reported as follows:
|
| After Cycle 6 (Week 17) |
| Number of Participants With a Clinical Response Assessed by Bone Scan | Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here. | Baseline, After Cycle 6 (Week 17) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| FACBC PET-CT |
Participants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement receiving Anti-3-[18F]FACBC radiotracer intravenously prior to PET scan. |
|
|
| Primary | Prostate Specific Antigen Level | Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer. | This analysis includes participants completing the study visits. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
|
|
|
| Primary | Number of Participants Responding to Treatment Assessed by MRI | Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:
| Data were not collected for this outcome measure as all participants had a CT scan rather than an MRI to assess response to treatment. | Posted | Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17) |
|
|
| Primary | Number of Participants Responding to Treatment Assessed by CT Scan | A CT will be used to assess response to treatment. Treatment response will be reported as follows:
| This analysis includes participants completing the study. | Posted | Count of Participants | Participants | After Cycle 6 (Week 17) |
|
|
|
| Primary | Number of Participants With a Clinical Response Assessed by Bone Scan | Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here. | This analysis includes participants who completed the study. | Posted | Count of Participants | Participants | Baseline, After Cycle 6 (Week 17) |
|
|
|
| Secondary | Number of Deaths | The number of deaths that have occurred was assessed at the end of study. | Posted | Count of Participants | Participants | End of Study (up to 1 year) |
|
|
|
| 3 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D000091662 |
| Genital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| After completing Cycle 6 |
|
|
| Progressive Disease |
|
| Difference in disease response: Progressive |
|