One-arm, Multi-center, Prospective Study to Assess the Safety and Efficacy of BioProtect Biodegradable Implantable Balloon in Prostate Cancer Subjects Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioProtect
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Safety of Balloon Implant
研究概览
简要总结
Primary Goal The study's primary goal is to assess the safety of the BioProtect biodegradable balloon implant and implantation procedure, in prostate cancer subjects undergoing routine XRT treatment. Safety of the BioProtect device will be assessed by reporting adverse events.
Secondary Goal The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness will be assessed in terms of increased distance between anterior rectal wall and prostate and noticeable reduction of isodose to the rectum.
详细描述
Primary Endpoint Parameters
The safety endpoint is incidence of complications related to BioProtect balloon implant and implantation procedure:
- Serious Adverse Events related to the BioProtect balloon and/or implantation procedure. Serious adverse event are defined as adverse requiring operation and/or associated with prolongation of hospital stay. Serious Adverse Events will be documented in Serious Adverse Event Form.
- Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse Events will be documented in Adverse Event Form.
- Subjective discomfort related to the balloon and implantation procedure will be assessed by pain analogue scale.
Secondary Endpoint Parameters
To assess the efficacy of BioProtect biodegradable balloon implant. Efficacy will be measured in terms of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged ≤
- •Men with child producing potential (that are not sterile) must accept using adequate contraceptive throughout the radiotherapy phase and for at least 3 months after completion of the radiotherapy phase when ever they have heterosexual intercourse.
- •Diagnosed prostate cancer not spread outside the capsule (T1 and T2).
- •Subject is scheduled for localized prostate XRT treatments.
- •Zubrod performance status 0-1; or Karnofsy >
- •Pre-randomization serum PSA lower than 25 (obtained prior to any LHRH or antiandrogen therapy); or Kattan nomogram less than 15 %.
- •Subject able to comprehend and give informed consent for participation in this study.
- •Probability of lymph node involvement based on Kattan nomogram less than 15 %.
- •Normal blood CBC and biochemistry up to two weeks before screening as follow:
- •Normal CBC
- •Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 10.0 g/dl
- •Adequate renal function, with serum creatinine ≤ 2.0 mg/dl
- •Adequate liver function, with serum bilirubin < 2.0 mg/dl
- •Adequate liver function with SGOT/SGPT < 2.5 x the upper normal limit
- •Normal values of the PT, PTT and INR tests.
- •Signed Informed Consent Form.
排除标准
- •Prior radical prostatectomy, cryosurgery or radiotherapy for prostate cancer, or other local therapy for prostate cancer.
- •Prior radiotherapy to the pelvis, including brachytherapy at the same body organ.
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- •Transmural myocardial infarction within the last 6 months prior to screening.
- •Acute infection requiring intravenous antibiotics at the time of screening.
- •Bleeding disorders.
- •Uncontrolled diabetes mellitus
- •HIV positive or any other immunosuppressive disorder.
- •Renal failure (Serum creatinine >2.0 mg/dl).
- •Inflammatory diseases of the perineal skin.
- •Urinary tract infection or acute or chronic prostatitis.
- •Active inflammatory bowel disease.
- •Rectal carcinoma.
- •Subjects after anterior resection of rectum or after rectal amputation.
- •Known cognitive disorder.
- •Concurrent participation in any other clinical study.
- •Physician objection.
研究组 & 干预措施
Balloon
Implantation of a biodegradable balloon spacer (absorbable perirectal spacer)
干预措施: Absorbable perirectal spacer (Device)
结局指标
主要结局
Safety of Balloon Implant
时间窗: 6 months
Assessed by collecting number of subjects experiencing a serious device related adverse event.
次要结局
- Efficacy Will be Measured in Terms of: Number of Participants With a Reduction in Radiation to the Rectum(6 months)