Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 10
- 主要终点
- Reduction in volume of rectum receiving radiation dose
研究概览
简要总结
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.
详细描述
Barrigel is composed of biodegradable material and maintains space for the entire course of prostate or prostate bed radiotherapy and is intended to be absorbed by the patient's body over time.
To evaluate the safety and effectiveness of Barrigel to reduce the radiation dose delivered to the anterior rectum by creating a space when injected between the rectum and the prostate bed in men receiving definitive external beam radiation therapy (intensity-modulated radiation therapy) for recurrence of prostate cancer after radical prostatectomy.
A prospective, randomized, controlled, single-masked multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
All subjects who sign a consent and meet inclusion and exclusion criteria will be randomized to the treatment or the control arm.
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
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
- •Documentation of an intra or interfascial radical prostatectomy
- •Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
- •No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan
- •Prostate specific antigen (PSA) 0.1 ng/mL or higher
- •Intent to receive definitive radiation therapy to the prostate bed
- •Written informed consent for study participation prior to study enrollment
排除标准
- •Known allergy to hyaluronic acid
- •Pathologic T4 disease
- •Prior local prostate cancer therapy including cryotherapy or brachytherapy.
- •Prior post-prostatectomy or pelvic radiation therapy
- •Planned elective pelvic lymph node radiation therapy
- •Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
- •Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
- •Active connective tissue disorder including lupus or scleroderma
- •Any urogenital abnormality that could limit the ability to access the Barrigel injection site
- •White blood cell count <4000/uL or >12,000/uL.
- •Hemoglobin <10 g/dL (transfusion or other intervention to achieve this is acceptable).
- •Active bleeding disorder or clinically significant coagulopathy defined as PTT >35 seconds or INR >1.4 or platelet count <100,000/mm
- •Serum AST/ALT >2.5 times the institutional upper limit of normal
- •Creatinine >2.0 mg/dL
- •Bilirubin >2.0 mg/dL
- •History of chronic renal failure.
- •History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose >300 mg/dL).
- •History of acquired immunodeficiency syndrome (AIDS). Patients with controlled HIV infection (CD4+ T-cell counts ≥ 350 cells/µL) and no history of AIDS-defining opportunistic infections may be included.
- •Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device).
- •Presence of bilateral hip implants, although unilateral hip implant may be permissible if the implant is MRI compatible and does not produce artifact that interferes with any requirements of the study protocol
- •Subject unable or unwilling to comply with study requirements
- •Any condition that in the investigator's opinion would prevent administration or completion of study therapy
结局指标
主要结局
Reduction in volume of rectum receiving radiation dose
时间窗: 3 months
Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects.
次要结局
- Grade 2 Toxicities(3 Months)
- Expanded Prostate Cancer Index Composite (EPIC) bowel QOL(3 months)
- Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL(3 months)