Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Correlation of SUVmax of Primary Tumors With SUVavg
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Carbon C 11 Choline (Drug)
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
干预措施: Fluorine F 18 Choline (Drug)
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
干预措施: Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Correlation of SUVmax of Primary Tumors With SUVavg
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: Day 1
The K1max values of primary tumors will be reported along with the standard deviation
Average Standardized Uptake Value (SUVavg)
时间窗: 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)
时间窗: Day 1
The average K1 values of primary tumors will be reported along with the standard deviation
Mean of the Standardized Uptake Value (SUVmax)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Albert J. Chang, MD, PhD
Assistant Professor
University of California, San Francisco