High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Primary Endpoint (HIFU): Identification of New Cancers
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-PSMA 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-PSMA 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-PSMA 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
- Non Randomized
- 干预模型
- Parallel
- 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
- •Biopsy consisting of ≥ 10 tissue cores sampled
- •PSA <20 ng/mL (for HIFU arm only)
- •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 (for HIFU arm only)
- •Patient considering focal HIFU therapy or robotic radical prostatectomy
排除标准
- •Previous local therapy for prostate cancer
- •Inability to receive PET tracer
- •Inability to receive MRI
- •Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2
- •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
ARM 2 (RP) - 18F-PSMA
10 mCi ±20% F18-PSMA injection
干预措施: 18F-PSMA (Drug)
ARM 1 (HIFU) - 18F-PSMA
10 mCi ±20% F18-PSMA injection
干预措施: 18F-PSMA (Drug)
结局指标
主要结局
Primary Endpoint (HIFU): Identification of New Cancers
时间窗: At time of pre-HIFU biopsy
The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
Primary Endpoint (HIFU):
时间窗: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery
The primary endpoint of the Phase II study is to assess the number of participants with biopsy-proven cancers that mpMRI would have missed compared with hrMRI and/or F18-PSMA PET.
次要结局
- Secondary Endpoint (HIFU):(6 months following standard HIFU therapy)
- Secondary Endpoint (Prostatectomy):(6 months following standard HIFU therapy)
研究者
Alessandro D'Agnolo
Co-Director Nuclear Medicine
Cedars-Sinai Medical Center