SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 51
- 主要终点
- Primary Safety Endpoint - Acute Grade 3 or greater adverse events.
研究概览
简要总结
To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
详细描述
HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.
Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System
Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects must meet the following criteria to be eligible for participation in the study:
- •Age ≥18 years old
- •Subjects must have had pathologically confirmed (by routine hematoxylin and eosin [H&E] staining) invasive adenocarcinoma of the prostate and planning to undergo EBRT
- •Subjects must meet ALL of the following:
- •Clinical stage T1-T2c (AJCC Ver. 8) tumor AND
- •Gleason Score 7 or less as determined from a biopsy taken within 12 months of the Baseline visit AND
- •Demonstrated blood prostate specific antigen (PSA) levels ≤20 ng/ml as measured within 6 months of the Baseline visit and prior to commencing androgen deprivation therapy (ADT)
- •Subject is able to provide written informed consent, approved by the appropriate Institutional Review Board/Ethics Committee/Research Ethics Board (IRB/EC/REB) of the respective clinical site
排除标准
- •Prostate > 80 cc
- •Subjects who are planning to undergo brachytherapy or focal boost
- •Subjects who have magnetic resonance imaging (MRI) evidence of gross posterior extracapsular extension (ECE) of the prostate cancer Note: MRI must be taken within 6 months prior to the Baseline visit
- •Subjects who have metastatic disease, other ongoing cancers which are being treated during the study or subjects for whom pelvic lymph node radiotherapy is planned
- •Subjects with any prior invasive solid tumor malignancy or hematologic malignancy (except non-melanomatous skin cancer) unless the subject has been disease free and treatment free for a minimum of 3 years
- •History of radical prostatectomy, other ablative anti-prostate cancer therapy (e.g., cryotherapy, high intensity focused ultrasound, irreversible electroporation) or previous pelvic irradiation (including prior prostate brachytherapy) at any time prior to screening
- •History of transurethral prostate surgery (e.g., Transurethral Needle Ablation (TUNA), Transurethral Microwave Therapy (TUMT), Transurethral Resection of the Prostate (TURP)) if performed within 1 year prior to screening
- •History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery
- •History of or current perirectal disease that may interfere with interpretation of study outcomes, including anal or perianal diseases such as fistula
- •Bleeding hemorrhoids requiring medical intervention within the prior three months
- •Diagnosed active bleeding disorder or a clinically significant coagulopathy, defined as PTT > 70s or aPTT>35s or INR > 1.4, or platelet count < 100,000 per mm3 Note: Subjects on anticoagulants may be included if the anticoagulant medication can be held for index procedure
- •Active inflammatory or infectious process involving the perineum, GI or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever >38⁰ C, WBC > 12,000/uL
- •Inability to undergo pelvic MRI or presence of implants causing severe artifact (e.g. bilateral arthroplasty) that interferes with imaging interpretation for this study at Investigator discretion
- •If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study
- •Unable to comply with the study requirements or follow-up schedule
- •Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient
- •Known PEG (polyethylene glycol) sensitivity or allergy
- •Known iodine sensitivity or allergy
- •ADT, if applicable, cannot or was not started 15-60 days prior to the pre-index procedure RT planning imaging and is planned to continue for a total planned duration greater than 6 months
研究组 & 干预措施
SpaceIT Hydrogel System
Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.
干预措施: SpaceIT Hydrogel System (Device)
Commercially available Boston Scientific Spacer
Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device.
干预措施: Commercially available Boston Scientific Spacer (Device)
结局指标
主要结局
Primary Safety Endpoint - Acute Grade 3 or greater adverse events.
时间窗: 90 Days from hydrogel placement procedure
Acute Grade 3 or greater adverse events, inclusive of all adverse events listed on the existing SpaceOAR product labels, that arise within 90 days of index procedure.
Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose
时间窗: 10 days post procedure
Clinically relevant dose reduction defined as a 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose in subjects receiving hydrogel.
次要结局
- Additional Safety Endpoint - Incidence of acute Grade 2 or greater gastrointestinal (GI) and genitourinary (GU) adverse events (AEs)(Up to 90 days)
- Additional Effectiveness Endpoint - Change in radiation dose distributions to the organs at risk(10 days post procedure)
- Additional Effectiveness Endpoint - Quality of Life Questionnaire, Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)(Baseline up to 24 months)
- Additional Effectiveness Endpoint - Absorption(12 Month post hydrogel placement)
- Additional Effectiveness Endpoint - Mean and Maximum Rectal Radiation doses(10 days post procedure)
- Additional Effectiveness Endpoint - Quality of Life Questionnaire: EQ-5D-5L(Baseline up to 24 months)
- Additional Effectiveness Endpoint - Ease of hydrogel administration(10 days post procedure)
- Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications(Up to 24 months)
- Additional Effectiveness Endpoint - Visualization of hydrogel(10 days post procedure)
- Additional Effectiveness Endpoint - Space Creation(10 days post procedure)
- Additional Safety Endpoint - Incidence of late Grade 2 or greater GI and GU adverse events (AEs)(91 days up to 24 Months)
- Additional Effectiveness Endpoint - Space Maintenance(3 Months post hydrogel placement procedure)
- Additional Effectiveness Endpoint - Quality of Life Questionnaire: Expanded Prostate Cancer Index Composite (EPIC-26)(Baseline up to 24 months)