Transperineal Injection of Cross-linked Hyaluronan Gel Into Anterior Perirectal Fat to Reduce Rectal Toxicity From High Dose Rate Brachytherapy and/or Intensity-Modulated Radiation Therapy for Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Mean rectal dose without Hylaform vs with Hylaform
研究概览
简要总结
The primary purpose of this study is to determine if cross-linked hyaluronan gel reduces the dose of radiation delivered to the rectum and the rectal toxicity of radiotherapy for localized prostate cancer.
详细描述
The main risk associated with transperineal injection of cross-linked hyaluronan gel into the anterior perirectal fat is infection. Prophylactic antibiotics will be given, resulting in a <5% risk. Another possible risk (<5%) is an allergic reaction such as itching. Patients who are allergic to avian products will be excluded from the study. Tenderness and pain at the injection site are possible. Bleeding, bruising, redness, or discoloration or the formation of a bump (granuloma) or scar (keloid) at the injection site is also possible. Embolization of cross-linked hyaluronan gel through the blood is a potential, rare complication if the gel is injected into a blood vessel rather than into fat. Prada et al. did not see any side effects related to the injection or the material itself in 27 patients based on a mean follow-up of 13 months (range: 9-22 months). Patients did not complain of pain, tenesmus, rectal pressure, or a sensation of rectal filling. Risks beyond 22 months are not well defined. Potential benefits of cross-linked hyaluronan gel include fewer rectal complications due to radiotherapy for early-stage prostate cancer.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed adenocarcinoma of the prostate, clinical stage T1c-T2c, NX, N0, M
- •Nodes determined to be negative by imaging methods will be classified as NX. Only nodes determined to be negative by surgical sampling will be classified as N
- •Prostate cancer biopsy grading by Gleason score classification is mandatory.
- •No prior pelvic radiotherapy. Induction hormonal therapy for less than or equal to 6 months is acceptable.
- •Prostate volume by TRUS < 50 cc prior to HDR brachytherapy.
- •Prostate specific antigen (PSA) less than or equal to 30 ng/ml.
- •Patient has provided informed consent.
排除标准
- •Clinical stage T3 or T
- •Clinical evidence of lymph node involvement (N1).
- •Clinical evidence of distant metastases (M1).
- •Radical surgery for carcinoma of the prostate.
- •Allergy to avian products.
- •Significant mental, medical, or physical impairment.
- •Employees of the Cancer Center of Irvine.
结局指标
主要结局
Mean rectal dose without Hylaform vs with Hylaform
时间窗: 8 months
次要结局
- Severity of late diarrhea without Hylaform vs with Hylaform(33 months)
- Rectal wall relative V60 and V70 without Hylaform vs with Hylaform(8 months)
- Severity of acute diarrhea during IMRT without Hylaform vs with Hylaform(8 months)
