High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
研究概览
简要总结
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
详细描述
This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.
Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.
Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate biopsy consisting of ≥ 10 tissue cores sampled
- •PSA </=20 ng/mL
- •Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
- •Patient considering focal HIFU therapy
排除标准
- •Previous local therapy for prostate cancer
- •Inability to receive PET tracer
- •Inability to receive MRI
- •Suggestion of extracapsular extension or seminal vesicle invasion on imaging
- •Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
- •Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
研究组 & 干预措施
18F-Fluciclovine
10mCi +/-20% 18F-fluciclovine injection
干预措施: 18F-Fluciclovine (Drug)
结局指标
主要结局
Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
时间窗: At time of post-imaging biopsy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)
Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
时间窗: At time of post-imaging biopsy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)
次要结局
- Negative Biopsy Rate (Number of Participants With Negative Biopsy)(6 months following standard HIFU therapy)
- Rate of High Grade Cancer (Number of Patients With High Grade Cancer)(6 months following standard HIFU therapy)
研究者
Timothy J. Daskivich
Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center
Cedars-Sinai Medical Center