Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGCarbon C 11 Choline
Given intravenously (IV) prior to imaging
DRUGFluorine F 18 Choline
Given intravenously (IV) prior to imaging
PROCEDUREPositron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Undergo whole-body PET/MR imaging
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: Patients must be \>=18 years of age * Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound. * Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10) * Karnofsky Performance Status \>=70 * Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan * Planned to undergo radical prostatectomy and extended pelvic lymph node dissection * Adequate bone marrow and organ function defined as follows: * Adequate bone marrow function: * Leukocytes \>= 3,000/microliter (mcL) * Absolute Neutrophil Count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Adequate hepatic function: * Total bilirubin - within normal institutional limits * Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 X institutional upper limit of normal * Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 X institutional upper limit of normal * Adequate renal function: * Creatinine - within normal institutional limits OR * Creatinine clearance \>= 60 mL/min/ 1.73m2 for patients with creatinine levels above institutional normal * Ability to understand a written informed consent document, and the willingness to sign it
Exclusion criteria
* Participation would significantly delay the scheduled standard of care therapy * Karnofsky performance status of \< 60 * Inadequate venous access * Administered a radioisotope within 5 physical half lives prior to study enrollment * Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of SUVmax of Primary Tumors With SUVavg | Day 1 | 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. |
| Correlation of K1 of Primary Tumors With K1max | Day 1 | 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. |
| Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg) | Day 1 | 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. |
| Correlation of K1max of Primary Tumors With SUVmax | Day 1 | 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. |
| Correlation of K1max of Primary Tumors With SUVavg | Day 1 | 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. |
| Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) | Day 1 | The average K1 values of primary tumors will be reported along with the standard deviation |
| Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max) | Day 1 | The K1max values of primary tumors will be reported along with the standard deviation |
| Average Standardized Uptake Value (SUVavg) | Day 1 | 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 |
| Mean of the Standardized Uptake Value (SUVmax) | Day 1 | 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. |
| Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | Day 1 | 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. |
| Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of SUVmax of Primary Tumors With Pathological Stage | Day 1 | 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. |
| Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores | After surgery, Up to 6 months | 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. |
| Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups | After surgery, Up to 6 months | 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. |
| Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level | Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
| Overall Study | Surgery not completed within protocol timeframe | 2 |
Baseline characteristics
| Characteristic | Diagnostic 11C- and 18F-choline PET/MR Imaging |
|---|---|
| Age, Customized 50-59 years old | 5 Participants |
| Age, Customized 60-69 years old | 8 Participants |
| Age, Customized 70-79 years old | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 18 participants |
| Serum Prostate-Specific Antigen (PSA) Level | 21.1 nanograms per millilitre (ng/mL) STANDARD_DEVIATION 18.5 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Choline PET/MR | Average Standardized Uptake Value (SUVavg) | 6.10 SUV | Standard Deviation 1.6 |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of K1max of Primary Tumors With SUVavg | 0.60 Spearman's correlation coefficient (ρ) |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of K1max of Primary Tumors With SUVmax | 0.65 Spearman's correlation coefficient (ρ) |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg) | 0.76 Spearman's correlation coefficient (ρ) |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of K1 of Primary Tumors With K1max | 0.86 Spearman's correlation coefficient (ρ) |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of SUVmax of Primary Tumors With SUVavg | 0.65 Spearman's correlation coefficient (ρ) |
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
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Choline PET/MR | Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1) | 0.562 K1 (min-1) | Standard Deviation 0.201 |
Primary
Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)
The K1max values of primary tumors will be reported along with the standard deviation
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Choline PET/MR | Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max) | 0.753 K1 (min-1) | Standard Deviation 0.246 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Choline PET/MR | Mean of the Standardized Uptake Value (SUVmax) | 8.40 SUV | Standard Deviation 2.04 |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | 88 percentage of true positives |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging | 100 percentage of true negatives |
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.
Time frame: After surgery, Up to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Choline PET/MR | Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups | Intermediate Risk Group | 9.53 SUVmax | Standard Deviation 1.48 |
| Choline PET/MR | Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups | High Risk Group | 6.24 SUVmax | Standard Deviation 1.26 |
p-value: <0.008Wilcoxon (Mann-Whitney)
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of SUVmax of Primary Tumors With Pathological Stage | 0.59 Spearman rank correlation coefficient (p |
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.
Time frame: After surgery, Up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores | 0.72 Spearman rank correlation coefficient (p |
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.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Choline PET/MR | Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level | 0.71 Spearman rank correlation coefficient (p |