Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 101
- 试验地点
- 16
- 主要终点
- Number of Device and Procedure Related Adverse Events
研究概览
简要总结
The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.
详细描述
Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions.
ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment.
Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
- •Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
- •Patient with PSA less than or equal to 20 ng/mL
- •Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
- •Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI
排除标准
- •Contraindications to MRI
- •History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
- •Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
- •Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
- •Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
- •Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
- •Bladder cancer
- •Urethral stricture/bladder neck contracture
- •Prostatitis NIH categories I, II and III
- •Implant near (<1 cm) the prostate
结局指标
主要结局
Number of Device and Procedure Related Adverse Events
时间窗: 12 months Post Treatment
The cumulative sum of adverse events was followed through Month 12 of the study.
Percentage of Subjects With NO Gleason Grade Group (GGG) Tissue in the Planned Region of Treatment (ROT) at 6 Months.
时间窗: 6 Months Post Treatment
The first primary effectiveness endpoint is within area of treatment (Region of Treatment, ROT) prostate biopsy occurring at 6-months post-treatment. Positive biopsy was defined as any Gleason Grade Group (GGG) tissue identified within the area of planned Exablate ROT. Negative biopsy was defined No Gleason Grade Group (GGG) tissue within the area of planned ROT.
Percentage of Subjects Showing a Reduction in PSA Value (Prostate Specific Antigen) From Baseline to 6-Months
时间窗: 6-months Post Treatment
The second primary effectiveness endpoint is the percentage of subjects experiencing a reduction in PSA value (Prostate Specific Antigen) from baseline to 6-months post-treatment. PSA values that increased or remained the same were considered an increase. Increased Prostate Specific Antigen levels in the blood is a common indication of prostate cancer. PSA results at 6 months - Value of ≤ 10ng/mL (Yes/No)
Percentage of Subjects With Non-Perfused Volume (NPV) Entirely Covered Target Gleason Grade Group (GGG) Tissue at Treatment.
时间窗: 6 Months Post Treatment
The final primary effectiveness endpoint is percentage of subjects with NPV complete coverage of targeted Gleason tissue at treatment. NPV (non-perfused volume) is the volume of tissue ablated/treated, a measure of the completeness/effectiveness of the ablation.
次要结局
- Functional Assessment of Cancer Therapy - Prostate (Fact-P) Trial Outcomes Index (TOI)(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- International Consultation on Incontinence Questionnaire (ICIQ-SF). Urinary Incontinence (ICIQ) Total Score(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- International Prostate Symptom Score (IPSS Total Score)(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- International Prostate Symptom Score (IPSS) - Quality of Life Score(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- International Index of Erectile Function (IIEF-15) Erectile Dysfunction Overall Satisfaction(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- Prostate Specific Antigen (PSA)(Baseline, 6 Months, 12 Months)
- Functional Assessment of Cancer Therapy - General (Fact-G) Total Score(Baseline, 3 Months, 6 Months, 9 Months, 12 Months.)
- Functional Assessment of Cancer Therapy - Prostate (Fact P) Total Score(Baseline, 3 Months, 6 Months, 9 Months, 12 Months)