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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00731 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| R01CA148708 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.
PRIMARY OBJECTIVES:
I. To assess the ability of 11C- and 18F-choline PET/MR to detect and localize prostate cancer within the prostate gland.
SECONDARY OBJECTIVES:
I. To assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical prostatectomy and extended pelvic lymph node dissection.
II. To assess the comparative performance of 11C- and 18F-choline PET/MR to already available imaging scans (bone scan, sodium fluoride positron emission tomography/computed tomography [NaF PET/CT], multiparametric1H magnetic resonance imaging [MRI], and/or pelvic CT scans) for detecting and localization of disease within the prostate, lymph nodes, and distant metastatic sites.
III. To determine the temporal distribution of 11C- and 18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be determined.
EXPLORATORY OBJECTIVES:
I. To compare regions of uptake on the 11C- and 18F-choline PET/MR to that on the sentinel lymph node imaging scans in patients undergoing sentinel lymph node-guided extended pelvic lymph node dissection.
OUTLINE:
Patients undergo 11C- and 18F-choline whole-body PET/MR imaging. After completion of study treatment, patients are followed up for 3 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic 11C- and 18F-choline PET/MR imaging | Experimental | Patients are given 370 megabecquerel (MBq) 11C-Choline (11C) intravenously and 3 MBq/kg 18F-Choline (18F) intravenously prior to a whole-body PET/MR imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon C 11 Choline | Drug | Given intravenously (IV) prior to imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) | The average K1 values of primary tumors will be reported along with the standard deviation | Day 1 |
| Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max) | The K1max values of primary tumors will be reported along with the standard deviation | Day 1 |
| Average Standardized Uptake Value (SUVavg) | The SUVavg values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy | Day 1 |
| Mean of the Standardized Uptake Value (SUVmax) | The SUVmax values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy. | Day 1 |
| Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | Sensitivity (True Positive Rate, TPR) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher sensitivity to identify the prostate cancer using SUVmax . The sensitivity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported. | Day 1 |
| Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level | A spearman rank correlation test was performed to test the correlation of SUVmax with a patients baseline PSA. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert J Chang, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27513849 | Result | Choi JY, Yang J, Noworolski SM, Behr S, Chang AJ, Simko JP, Nguyen HG, Carroll PR, Kurhanewicz J, Seo Y. 18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons. Radiology. 2017 Feb;282(2):429-436. doi: 10.1148/radiol.2016160220. Epub 2016 Aug 11. |
| Label | URL |
|---|---|
| Link to Publication for NCT02397408 | View source |
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Patients were recruited from the Division of Radiation Oncology, Division Urological Medical Oncology, and the Division of Urologic Surgical Oncology at the Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco (UCSF) who are planning to undergo radical prostatectomy of definitive radiation therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic 11C- and 18F-choline PET/MR Imaging | Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic 11C- and 18F-choline PET/MR Imaging | Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) | The average K1 values of primary tumors will be reported along with the standard deviation | Posted | Mean | Standard Deviation | K1 (min-1) | Day 1 |
|
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1 day, up to 30 minutes after injection
Only NCI Common Terminology Criteria for Adverse Events (CTCAE) of grade 3 or higher were collected for this study.
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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 | Diagnostic 11C- and 18F-choline PET/MR Imaging | Patients are given 370MBq 11C-Choline intravenously and 3MBq/kg 18F-Choline intravenously prior to a whole-body PET/MR imaging |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert J. Chang, MD, PhD | University of California, Los Angeles | (310) 82509771 | ajchang@mednet.ucla.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 |
|---|---|
| C514960 | fluorocholine |
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Fluorine F 18 Choline | Drug | Given intravenously (IV) prior to imaging |
|
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| Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI) | Procedure | Undergo whole-body PET/MR imaging |
|
|
Specificity (True Negative Rate) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher specificity to identify the prostate cancer using SUVmax. The specificity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported. |
| Day 1 |
| Correlation of K1 of Primary Tumors With K1max | A spearman rank correlation test was performed to test the correlation of K1 with K1max. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg) | A spearman rank correlation test was performed to test the correlation of K1 with the SUVavg of primary tumors. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Correlation of K1max of Primary Tumors With SUVmax | A spearman rank correlation test was performed to test the correlation of K1max with SUVmax. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Correlation of K1max of Primary Tumors With SUVavg | A spearman rank correlation test was performed to test the correlation of K1max with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Correlation of SUVmax of Primary Tumors With SUVavg | A spearman rank correlation test was performed to test the correlation of SUVmax with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Day 1 |
| Correlation of SUVmax of Primary Tumors With Pathological Stage | The system of pathological staging is developed by the American Joint Committee on Cancer (AJCC) and is divided into 5 stages: stage 0 (zero) and stages I through IV (1 through 4). A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's baseline pathological stage. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Day 1 |
| Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores | The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's CAPRA score after surgery. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | After surgery, Up to 6 months |
| Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups | The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A Mann-Whitney U test was performed to compare the SUVmax with patients classified as intermediate-risk and high risk based on their CAPRA Score. Means and standard deviations will be reported. | After surgery, Up to 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum Prostate-Specific Antigen (PSA) Level | Prostate-specific antigen (PSA) is a protein made by cells in the prostate gland (both normal cells and cancer cells) | Baseline PSA was calculated for patients whom completed and were used in final analysis | Mean | Standard Deviation | nanograms per millilitre (ng/mL) |
|
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| Primary | Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max) | The K1max values of primary tumors will be reported along with the standard deviation | Posted | Mean | Standard Deviation | K1 (min-1) | Day 1 |
|
|
|
| Primary | Average Standardized Uptake Value (SUVavg) | The SUVavg values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy | Posted | Mean | Standard Deviation | SUV | Day 1 |
|
|
|
| Primary | Mean of the Standardized Uptake Value (SUVmax) | The SUVmax values of primary tumors will be reported along with the standard deviation. Typically, a standardized uptake value (SUV), a quantity that incorporates the patient's size and the injected dose, that is more than 2.0 is considered to be suggestive of malignancy. | Posted | Mean | Standard Deviation | SUV | Day 1 |
|
|
|
| Primary | Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | Sensitivity (True Positive Rate, TPR) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher sensitivity to identify the prostate cancer using SUVmax . The sensitivity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported. | Posted | Number | percentage of true positives | Day 1 |
|
|
|
| Primary | Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | Specificity (True Negative Rate) measures the ability of a 11C- and 18F-Choline PET/MR Imaging for Prostate Cancer to correctly identify patient status as respectively diseased or non-dis- eased and is reported as a percentage ranging from 0 -100 with higher percentages indicating a higher specificity to identify the prostate cancer using SUVmax. The specificity of the combined PET and MR imaging for prediction of pathologic extraprostatic extension will be reported. | Posted | Number | percentage of true negatives | Day 1 |
|
|
|
| Primary | Correlation of K1 of Primary Tumors With K1max | A spearman rank correlation test was performed to test the correlation of K1 with K1max. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman's correlation coefficient (ρ) | Day 1 |
|
|
|
| Primary | Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg) | A spearman rank correlation test was performed to test the correlation of K1 with the SUVavg of primary tumors. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman's correlation coefficient (ρ) | Day 1 |
|
|
|
| Primary | Correlation of K1max of Primary Tumors With SUVmax | A spearman rank correlation test was performed to test the correlation of K1max with SUVmax. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman's correlation coefficient (ρ) | Day 1 |
|
|
|
| Primary | Correlation of K1max of Primary Tumors With SUVavg | A spearman rank correlation test was performed to test the correlation of K1max with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman's correlation coefficient (ρ) | Day 1 |
|
|
|
| Primary | Correlation of SUVmax of Primary Tumors With SUVavg | A spearman rank correlation test was performed to test the correlation of SUVmax with SUVavg. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman's correlation coefficient (ρ) | Day 1 |
|
|
|
| Secondary | Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level | A spearman rank correlation test was performed to test the correlation of SUVmax with a patients baseline PSA. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman rank correlation coefficient (p | Day 1 |
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|
|
| Secondary | Correlation of SUVmax of Primary Tumors With Pathological Stage | The system of pathological staging is developed by the American Joint Committee on Cancer (AJCC) and is divided into 5 stages: stage 0 (zero) and stages I through IV (1 through 4). A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's baseline pathological stage. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman rank correlation coefficient (p | Day 1 |
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| Secondary | Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores | The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A spearman rank correlation test was performed to test the correlation of SUVmax with a patient's CAPRA score after surgery. Spearman's correlation coefficient (ρ) determines the strength and direction of the monotonic relationship between two variables. The Spearman correlation coefficient is reported in values from +1 to -1. A ρ= +1 indicates a perfect association of ranks, a ρ = zero indicates no association between ranks and a ρ = -1 indicates a perfect negative association of ranks. The closer ρ is to zero, the weaker the association between the ranks. | Posted | Number | Spearman rank correlation coefficient (p | After surgery, Up to 6 months |
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| Secondary | Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups | The CAPRA is a 5 item questionnaire completed by the clinicians with a total score range from 0-10 calculated using points assigned to: age at diagnosis, PSA at diagnosis, Gleason score of the biopsy, clinical stage and percent of biopsy cores involved with cancer. A CAPRA score of 0 to 2 indicates low-risk, a score of 3 to 5 indicates intermediate-risk, and a score of 6 to 10 indicates high-risk. A Mann-Whitney U test was performed to compare the SUVmax with patients classified as intermediate-risk and high risk based on their CAPRA Score. Means and standard deviations will be reported. | Posted | Mean | Standard Deviation | SUVmax | After surgery, Up to 6 months |
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| 18 |
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| 18 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |