Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Carbon C 11 Choline
- Conditions
- Prostate Cancer
- Sponsor
- University of California, San Francisco
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Correlation of SUVmax of Primary Tumors With SUVavg
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
Albert J. Chang, MD, PhD
Assistant Professor
University of California, San Francisco
Eligibility Criteria
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
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.
Arms & Interventions
Diagnostic 11C- and 18F-choline PET/MR imaging
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
Intervention: Carbon C 11 Choline
Diagnostic 11C- and 18F-choline PET/MR imaging
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
Intervention: Fluorine F 18 Choline
Diagnostic 11C- and 18F-choline PET/MR imaging
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
Intervention: Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Outcomes
Primary Outcomes
Correlation of SUVmax of Primary Tumors With SUVavg
Time Frame: 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
Time Frame: 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.
Sensitivity of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging
Time Frame: 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.
Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)
Time Frame: Day 1
The K1max values of primary tumors will be reported along with the standard deviation
Average Standardized Uptake Value (SUVavg)
Time Frame: 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 Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1)
Time Frame: Day 1
The average K1 values of primary tumors will be reported along with the standard deviation
Mean of the Standardized Uptake Value (SUVmax)
Time Frame: 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.
Specificity of of Combined Positron Emission Tomography (PET) and Magnetic Resonance (MR) Imaging
Time Frame: 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.
Correlation of K1max of Primary Tumors With SUVmax
Time Frame: 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 K1 of Primary Tumors With Average Standardized Uptake Value (SUVavg)
Time Frame: 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 SUVavg
Time Frame: 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.
Secondary Outcomes
- Correlation of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Scores(After surgery, Up to 6 months)
- Correlation of SUVmax of Primary Tumors With Serum Prostate-specific Antigen (PSA) Level(Day 1)
- Correlation of SUVmax of Primary Tumors With Pathological Stage(Day 1)
- Comparison of SUVmax of Primary Tumors With Post-surgical Cancer of the Prostate Risk Assessment (CAPRA) Score Groups(After surgery, Up to 6 months)