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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA139687 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV administration of fluorine-18 fluorocholine followed by PET/CT imaging | Drug | Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer. | Concurrent with PET Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandi A Kwee, MD | The Queen's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26912444 | Derived | Lee J, Sato MM, Coel MN, Lee KH, Kwee SA. Prediction of PSA Progression in Castration-Resistant Prostate Cancer Based on Treatment-Associated Change in Tumor Burden Quantified by 18F-Fluorocholine PET/CT. J Nucl Med. 2016 Jul;57(7):1058-64. doi: 10.2967/jnumed.115.169177. Epub 2016 Feb 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses. IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses. IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age (10-year groupings) | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT | The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer. | Outcome Measure Data Table reflects data from the 22 subjects completing the current study. | Posted | Number | %PET-positive cases in a given PSA range | Concurrent with PET Procedure |
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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 | Single Arm | Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses. IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy. | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandi Kwee, Principal Investigator | The Queen's Medical Center | 808-691-5466 | skwee@queens.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Title | Measurements |
|---|
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| 60-69 years |
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| 70-79 years |
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| 80-89 years |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| PSA <= 0.5 ng/mL (0 cases) |
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