Translation of High-intensity Focused Ultrasound (HIFU) or Treatment of Intermediate and High-Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment
研究概览
简要总结
This phase II trial studies how well high-intensity focused ultrasound works in treating participants with intermediate and high-risk prostate cancer. High-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam which may target and destroy a specific part of the prostate, while minimizing damage to surrounding structures and tissue.
详细描述
PRIMARY OBJECTIVES:
I. Histologic assessment of cancer kill in the post high-intensity focused ultrasound (HIFU) needle biopsy and excised treated lobe 2-4 weeks after treatment with HIFU.
II. Radiologic assessment of areas suspicious for residual cancer in the treated lobe on multiparametric magnetic resonance imaging (mpMRI) and/or contrast enhanced ultrasound (CEUS) 2-4 weeks post-HIFU (immediately prior to radical prostatectomy).
SECONDARY OBJECTIVES:
I. Assessment of differences in tumor microenvironment, specifically upregulation of the immune system, before and after HIFU treatment on both the treated and untreated lobes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male having a diagnosis of clinically-significant prostate cancer (CsPCa) made within the past 12 months (Gleason 7-9) with no evidence of metastatic disease; all outside pathology will be re-reviewed at University of Southern California (USC) to verify diagnosis
- •Patients have elected to undergo radical prostatectomy (RP) as treatment of choice and have to be a surgical candidate for RP; this determination will be made by the patient in conjunction with their treating urologist and is current standard of practice
- •Standard preoperative evaluation is performed and deemed satisfactory to proceed to surgery as per their treating urologist
- •Ability to understand AND willingness to sign a written informed consent
- •Patients must be willing to undergo HIFU, CEUS, MRI and prostate biopsy pre-RP for research purposes
排除标准
- •Patients may not be receiving any other investigational agents or have received any definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder tumors [EBRT], Brachytherapy etc) prior
- •Patients with known metastases would be excluded from this clinical trial
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinical significant cardiac arrhythmia (rate controlled atrial fibrillation allowed), or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptable
- •Patients with rectal disease
- •Patients who are unable to undergo MRI
- •Patients with convincing evidence of extraprostatic extension or T4 disease on digital rectal examination (DRE)
研究组 & 干预措施
Treatment (HIFU, radical prostatectomy)
HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours.
PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
干预措施: Contrast-Enhanced Ultrasound (Procedure)
Treatment (HIFU, radical prostatectomy)
HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours.
PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
干预措施: High-Intensity Focused Ultrasound (Device)
Treatment (HIFU, radical prostatectomy)
HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours.
PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (HIFU, radical prostatectomy)
HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours.
PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
干预措施: Multiparametric Magnetic Resonance Imaging (Procedure)
Treatment (HIFU, radical prostatectomy)
HIFU PHASE: Participants undergo mpMRI and CEUS pre-HIFU treatment and then CEUS post-HIFU treatment. Participants then undergo HIFU treatment over 2-2.5 hours.
PROSTATECTOMY PHASE: Within 2-4 weeks post-HIFU treatment, participants undergo mpMRI 1-2 days prior to radical prostatectomy. On the day of surgery, participants undergo CEUS prior to radical prostatectomy.
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
Mean percentage of viable clinically-significant prostate cancer (Gleason pattern 4 or 5) after high-intensity focused ultrasound (HIFU) treatment
时间窗: Up to 3 months
Determined by calculating the mean percent of viable cancer tissue remaining after HIFU using two different measurements: histologic examination of excised prostate specimen and histologic examination of post HIFU needle biopsy. Each of these two measurements will be investigated independently using two types of analyses as follows: percent viable cancer in excised prostate specimen and percent viable cells using post-HIFU needle biopsy. Will calculate the mean percent viable cancer across patients along with a corresponding 95% confidence interval based on all 32 fully evaluable patients.
次要结局
- Mean detection level of immunological factors(Up to 3 months)