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| ID | Type | Description | Link |
|---|---|---|---|
| FACBC2 | Other Identifier | Other |
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The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.
Prostate cancer is the most common solid tumor, with approximately 200,000 new cases diagnosed per year. Several different local therapies are available for treatment, including surgery and radiotherapy. Significant advances have been made which have improved the cancer control outcomes and treatment. Despite these significant advances, approximately 30% of patients treated with definitive local therapy experience recurrent disease. Recurrent (returning) disease usually displays rising Prostate-Specific Antigen (PSA) (a blood test for prostate cancer). The PSA level is often of limited use in differentiating local recurrence (i.e. recurrence in the prostate bed) from recurrence outside of the prostate bed (extra-prostatic recurrence). Imaging plays a central role in the detection of recurrent prostate carcinoma in the prostate bed and in the differentiation of prostatic from extraprostatic recurrence. There are newer methods of imaging such as magnetic resonance imaging (MRI) and positron emission tomography (PET) with molecular radiotracers that are currently under study for the imaging of post-therapy recurrence.
One PET radiotracer which has shown promise in the staging and restaging of patients with prostate carcinoma is anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (anti-3-[18F]FACBC) which is a synthetic amino acid analog. FACBC demonstrated higher accuracy compared with other methods in the restaging of patients with suspected recurrent prostate carcinoma. FACBC has been tested in over 140 subjects in other studies in the Emory system including 128 subjects with prostate cancer.
The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-[18F] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA.
All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate. Biopsy of the suspected recurrence sites will be scheduled at the subjects' convenience as soon as possible after the scans.
Tissue obtained from the biopsy will undergo standard analysis to determine if prostate carcinoma cells are present. The secondary aim is to use left-over biopsy material to determine if there are genotypic differences between prostate carcinoma recurrence confined to the prostate bed and extraprostatic recurrence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACBC | Experimental | Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT detection of cancer recurrence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACBC | Drug | Participants will receive a bolus of anti-[18F]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)). |
| Measure | Description | Time Frame |
|---|---|---|
| The Presence of Cancer Tissue Inside of the Prostate Bed | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:
| Up to 43 months |
| The Presence of Cancer Tissue Outside of the Prostate Bed | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:
| Up to 43 months |
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Inclusion Criteria:
Exclusion Criteria:
Age less than 18.
Greater than T3 disease in past and/or treated with prostatectomy.
Less than 1 year since cryotherapy,external beam radiation therapy, or HiFU or 2 years since brachytherapy..
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 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation).
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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 |
|---|---|---|---|
| 29685521 | Result | Akin-Akintayo O, Tade F, Mittal P, Moreno C, Nieh PT, Rossi P, Patil D, Halkar R, Fei B, Master V, Jani AB, Kitajima H, Osunkoya AO, Ormenisan-Gherasim C, Goodman MM, Schuster DM. Prospective evaluation of fluciclovine (18F) PET-CT and MRI in detection of recurrent prostate cancer in non-prostatectomy patients. Eur J Radiol. 2018 May;102:1-8. doi: 10.1016/j.ejrad.2018.02.006. Epub 2018 Feb 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FACBC | Participants receiving a bolus of anti-[18F]FACBC injected with positron emission tomography (PET)-computerized tomography (CT) (PET-CT) and a multiparametric MRI (mpMR) for detection of cancer recurrence. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants completing both scans are included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | FACBC | Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence. |
| 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 | The Presence of Cancer Tissue Inside of the Prostate Bed | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:
| The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (22 out of 24 participants who received both scans). The remaining two had no biopsy or had insufficient follow-up information to reach a consensus about disease status. | Posted | Count of Participants | Participants | Up to 43 months |
|
Adverse events related to the study procedures were collected from the time a participant consented to take part in the trial through all study related procedures (up to 29 days, which is the maximum number of days between a participant receiving both imaging tests). Adverse events related to the study procedures were not expected.
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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 | Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence. |
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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 | Dec 4, 2014 | Dec 12, 2018 | Prot_SAP_000.pdf |
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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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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PET-MR Interval | Median | Full Range | days |
|
| Prior prostate cancer therapy | Count of Participants | Participants |
|
| Prostate-Specific Antigen (PSA) | Mean | Standard Deviation | Nanograms per milliliter (ng/ml) |
|
| OG000 | FACBC | Participants receiving a bolus of anti-[18F]FACBC injected with PET-CT and a multiparametric MRI for detection of cancer recurrence. |
|
|
| Primary | The Presence of Cancer Tissue Outside of the Prostate Bed | Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:
| The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (18 out of 24 participants who received both scans). | Posted | Count of Participants | Participants | Up to 43 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
|
| False Negatives |
|
| mpMR Reader 1 |
|
| mpMR Reader 2 |
|