Moderate Hypofractionated Radiotherapy (62 Gy in 20 Fractions of 3.1 Gy) Versus Stereotactic Radiotherapy (37.5 Gy in 5 Fractions of 7.5 Gy) With Hyaluronic Acid Injection Between the Prostate and the Rectum for Prostate Cancer of Low- to Intermediate Risk; RPAH2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 7
- 主要终点
- Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).
研究概览
简要总结
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate.
Ninety-six patients and 9 centers are included in the protocol.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age superior or equal to 18 years and inferior to 80 years.
- •patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation.
- •prostate cancer histologically proven.
- •performance index OMS (World Health Organization) of grade 0-
- •indication of external beam radiotherapy validate by the medical commission of the institution.
- •IPSS (International Prostate Symptom Score < 15/35 (without alpha-blocker).
- •the signed consent form.
排除标准
- •Rectal surgery antecedents.
- •prostate resection less than 6 mois.
- •Involvement of the seminal vesicles or of the capsule on MRI.
- •patient who can't cooperate during the treatment.
- •pelvic irradiation antecedents.
- •antecedents of inflammatory intestinal pathologies.
- •neoplasia.
- •patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect).
- •patients receiving anticoagulant treatment.
- •other undergoing study that may interfere with the present study.
- •patient under legal protection measure.
- •hypersensitivity to hyaluronic acid.
- •patient with auto-immune disease.
- •patient receiving immunosuppressive medication.
- •severe allergies.
- •history of endocarditis.
研究组 & 干预措施
Moderate Hypofractionated radiotherapy (62Gy)
20 fractions of 3.1Gy
干预措施: Moderate hypofractionated radiotherapy (Radiation)
Stereotactic radiotherapy (37.5Gy)
5 fractions of 7.5Gy)
干预措施: Stereotactic radiotherapy (Radiation)
结局指标
主要结局
Number of patients with late urinary toxicities of grade ≥ 2 after moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and after stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy).
时间窗: Follow-up at ≥ 3 months after the radiotherapy and up to 3 years.
Late urinary toxicities of grade ≥ 2 assessed using the Common Toxicity Criteria for Adverse Effects ( CTCAE) v 4.0 classification from 3 months to 3 years.
次要结局
- Late rectal toxicities in both arms, for the evaluation of the hyaluronic acid efficacy to preserve the rectal wall in both approaches.(3 years.)
- Evaluation and comparison of the sexual preservation rates in both arms.(3 years.)
- Survival rates without biological relapse in both arms.(3 years.)
- Evaluation and comparison of the acute urinary and rectal toxicities in both arms.(3 months: evaluation at 3 months.)