WATER IV PCa (AS Sub-study)
WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Angela Lee
- 电话号码：650-232-7215
- 邮箱：a.lee@procept-biorobotics.com
学习地点
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Arizona
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Chandler、Arizona、美国、85224
- Arizona Clinical Trials
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California
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Los Angeles、California、美国、90089
- University of Southern California
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Murrieta、California、美国、92562
- Tri Valley Urology
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Colorado
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Boulder、Colorado、美国、80304
- Boulder Medical Center
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Florida
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Delray Beach、Florida、美国、33484
- Advanced Research
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Miami、Florida、美国、33146
- University of Miami
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Georgia
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Atlanta、Georgia、美国、30328
- Georgia Urology
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Idaho
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Idaho Falls、Idaho、美国、83401
- Mountain View Hospital
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Glenview、Illinois、美国、60026
- Endeavor Health
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University
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Missouri
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North Kansas City、Missouri、美国、64116
- Kansas City Urology Care
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Nebraska
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Kearney、Nebraska、美国、68847
- Kearney Urology Center
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Omaha、Nebraska、美国、68114
- Adult & Pediatric Urology
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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New York
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Albany、New York、美国、12208
- Albany Medical College
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New York、New York、美国、10016
- Integrated Medical Professionals, PLLC
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Rochester、New York、美国、14642
- University of Rochester Medical Center
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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South Carolina
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Charleston、South Carolina、美国、29425
- MUSC Hollings Cancer Center
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Murrells Inlet、South Carolina、美国、29576
- Tidelands Health Urology
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Texas
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Austin、Texas、美国、78745
- Urology Austin
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Dallas、Texas、美国、75231
- Urology Clinics of North Texas
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Wisconsin
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Sheboygan、Wisconsin、美国、53081
- Advocate Aurora Research Institute
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Shatin、香港
- Chinese University of Hong Kong
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Biological male with age ≥ 45 years at the time of consent
- Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
- First prostate cancer diagnoses within 18 months (545 days) of consent
- Are candidates for active surveillance
- Clinical Stage ≤ T2c
- PSA < 15 ng/ml
- Prostate volume ≥25 ml
Exclusion Criteria:
- Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.
- Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.
- Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.
- Patient is unwilling to accept a blood transfusion if required.
- Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:
5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).
6. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.
7. Patient currently participating in other studies unless approved by Sponsor in writing.
8. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3).
9. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：水消融疗法
Aquablation 治疗臂将通过 AQUABEAM 机器人系统或 HYDROS 机器人系统接受 Aquablation
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AquaBeam 机器人系统和 HYDROS 机器人系统利用高速无菌盐水射流切除前列腺组织，并通过膀胱镜检查和经直肠超声成像进行实时可视化引导。
这种微创外科手术称为水消融疗法。
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有源比较器：Active Surveillance
The active surveillance arm will receive standard-of-care for prostate cancer management.
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Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression.
Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Freedom from GG ≥ 2
大体时间：12 Months
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12 Months
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次要结果测量
结果测量 |
大体时间 |
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Freedom from persistent or increased MRI suspicion AND additional prostate cancer treatment
大体时间：3 Years
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3 Years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.