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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 |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to determine whether imaging with 18F-choline PET/CT can provide information that may help guide subsequent investigational or clinical treatments for patients with advanced (hormone-refractory) metastatic prostate cancer.
Patients who meet eligibility criteria and are enrolled will undergo whole-body imaging with 18F-choline PET/CT at 3 time points during the course of treatment that is indicated for castrate resistant prostate cancer. The 1st PET/CT scan is performed at baseline before treatment initiation. The 2nd and 3rd scans are performed at two other treatment-releated timepoints or at approximately 1 month and 3 months after treatment initiation. Change in lesion 18F-choline uptake from baseline measured at each time point will be determined. Cancer 18F-choline uptake will be evaluated as a marker of therapeutic response in comparison to PSA response and symptom scores. Treatment-related changes in tumor 18F-choline uptake occur will be studied after the second and third PET scans to determine the acuity by which changes in tumor 18F-choline uptake can be expected following specific treatments for castrate-resistant prostate cancer. The study evaluates a diagnostic intervention and the treatments themselves are not considered part of the investigation. All treatment decisions will be made independent of the study and must be deemed clinically-warranted by a treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received 18F-fluorocholine PET/CT | Experimental | IV fluorine-18 labeled methylcholine before PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV fluorine-18 labeled methylcholine before PET/CT | Drug | Intervention at pre-treatment, and at two timepoints post treatment intiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolically Active Tumor Volume (MATV) Response | Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT | 21 to 98 days |
| Time to PSA Progression | Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%. | 2 years |
| Proportional Hazards Regression Analysis of Time to PSA Progression | PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines. | Up to 15 week post-chemotherapy |
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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 | Received 18F-fluorocholine PET/CT | 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation to determine Metabolically Active Tumor Volume (MATV) Response (30% or greater decline in MATV). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. |
| 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 | Metabolically Active Tumor Volume (MATV) Response | Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT | Posted | Count of Participants | Participants | 21 to 98 days |
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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 | 18F-fluoromethylcholine IV in conjunction with PET/CT imaging IV fluorine-18 labeled methylcholine before PET/CT: Intervention at pre-treatment, and at two timepoints post treatment intiation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandi Kwee, MD, PhD | The Queen's Medical Center | 8086915466 | skwee@queens.org |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Time to PSA Progression | Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%. | Posted | Mean | Standard Error | days | 2 years |
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|
|
| Primary | Proportional Hazards Regression Analysis of Time to PSA Progression | PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines. | Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response. | Posted | Number | 95% Confidence Interval | Hazard Ratio | Up to 15 week post-chemotherapy |
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|
| 5 |
| 45 |
| 0 |
| 45 |
| Cellulitis | Infections and infestations | Non-systematic Assessment |
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| Myocardial Ischemia, Diagnosis | Cardiac disorders | Non-systematic Assessment |
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| Severe Influenza | Infections and infestations | Non-systematic Assessment |
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| Obstructive Uropathy | Renal and urinary disorders | Non-systematic Assessment |
|
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