CLINICAL PROTOCOL for the INVESTIGATION Of the BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioProtect
- 入组人数
- 222
- 试验地点
- 26
- 主要终点
- Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure
研究概览
简要总结
The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the balloon to reduce the radiation dose delivered to the anterior rectum. The balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
详细描述
This study will be a prospective, multi-center, randomized, double-arm, single blind, concurrently controlled study to assess the safety and efficacy of the balloon in prostate cancer subjects undergoing radiotherapy by means of intensity modulation radiation therapy (IMRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Study subjects are blinded to group assignment.
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
- •Be at least 18 years of age
- •Have been histologically diagnosed with invasive adenocarcinoma of the prostate, at clinical stage T1-T3 (as determined by a biopsy taken within 9 months of the screening visit)
- •Be scheduled for radiation therapy (XRT) by means of IMRT
排除标准
- •Any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years
- •Prior radical prostatectomy
- •Prior cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer
- •Prior radiotherapy to the pelvis, including brachytherapy
- •History of prior surgery involving the rectum or anus
- •Prior surgical procedure involving the peri-rectal and/or peri-prostatic area
结局指标
主要结局
Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure
时间窗: Within 6 months from balloon implantation
Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)
时间窗: 3 months
Observed reduction of at least \>25% in rectal volume receiving 70 Gy (rV70) in patients after spacer implantation, with efficacy of the study confirmed if \>75% of balloon recipients achieved this degree of dose reduction.
次要结局
未报告次要终点