NCT04087980已完成不适用
Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Francis Medical Inc.9 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 9
- 主要终点
- Serious device related adverse events
研究概览
简要总结
The purpose of this research study is to collect information on a new treatment of prostate tissue participants with intermediate risk prostate cancer using a medical device called the Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the prostate where cancer has been identified. The medical device delivers thermal energy in the form of water vapor to the prostate tissue through the urethra. Previous research has shown successful prostate tissue ablation. Additional research may help show successful ablation of the prostate tissue where cancer is located.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •45-80 years old
- •Biopsy confirmed unilateral, adenocarcinoma of the prostate
- •Minimum of 12 biopsy cores obtained ≥4 weeks and ≤12 months before treatment. Targeted fusion biopsy is preferred if there is a MRI PI-RADs ≥3 lesion. It is preferred a standard 12 sector biopsy is mapped. MRI required if biopsy was completed >6 months prior to treatment date to confirm no MRI progression of disease that would be considered exclusionary.
- •≤4 of 6 standard sector biopsy cores positive for prostate cancer (unilateral); positive core(s) from a targeted lesion count as one positive core.
- •Gleason score of 7 (3+4) / International Society of Urological Pathologists (ISUP) Gleason Grade Group (GGG) 2
- •Clinical Stage less than or equal to T2b N0 M0
- •PSA (Prostate Specific Antigen) less than or equal to 15ng/mL
- •Prostate size 20-80cc
排除标准
- •Malignant tumors identified by extraprostatic extension, sphincter involvement/lesion abutment seminal vesicle invasion or lymph node invasion or metastasis
- •Narrow Peripheral Zone
- •MRI identified PI-RADs ≥4 lesion contralateral to the side that has biopsy confirmed adenocarcinoma
- •Prior definitive treatment of prostate cancer
结局指标
主要结局
Serious device related adverse events
时间窗: 180-day follow-up
次要结局
- Participants evaluated for Gleason pattern 4 or higher disease on the treated side identified from biopsy(180-day follow-up)
- Changes from baseline with the size of the prostate via MRI (Magnetic Resonance Imaging)(180-day follow-up)
- Participants evaluated for Gleason pattern 4 or higher disease on the contralateral side identified from biopsy(180-day follow-up)
- Changes from baseline in the Expanded Prostate Cancer Index Questionnaire (EPIC)(180-day follow-up)
- Changes from baseline in the International Prostate Cancer Symptom Score (IPSS)(180-day follow-up)
- Participants evaluated for biopsy negative on the treated side(180-day follow-up)
- Changes from baseline with the PSA (Prostate Specific Antigen)(Up to 1 Year)
- Changes from baseline in the International Index of Erectile Function Questionnaire (IIEF)(180-day follow-up)
- Changes from baseline in the Male Sexual Health Ejaculatory Function Short Form Questionnaire (MSHQ-EjD)(180-day follow-up)
- Adverse events, serious and non-serious, related and unrelated, will be collected on all patients enrolled(Up to 1 Years)
- Participants evaluated for biopsy negative on the contralateral side(180-day follow-up)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
2 期
PET/MR for Prostate Cancer Restaging: a Phase II Prospective Monocentric StudyProstate CancerNCT05806853IRCCS San Raffaele60
进行中（未招募）
不适用
Targeted Microwave Tissue Coagulation for Prostate CancerProstate CancerNCT06430749Osamu Ukimura65
已完成
不适用
Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate CancerProstate CancerNCT00773305Summa Health System200
撤回
不适用
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate BrachytherapyStage III Prostate AdenocarcinomaNCT02597894Jonsson Comprehensive Cancer Center
Unknown
不适用
ClariCore Optical Biopsy System Used in TRUS (Trans-Rectal Ultrasound)-Guided Prostrate BiopsyCellular Diagnosis, Prostate CancerNCT02928640Precision Biopsy, Inc.200