ACTRN12621000056897已完成未知
A prospective phase II trial investigating the safety and efficacy of SpaceOAR® hydrogel in patients with prostate cancer receiving dose escalated radiotherapy to 82Gy
Epworth HealthCare0 个研究点目标入组 71 人开始时间: 2021年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 71
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Pathologically confirmed clinical stage T1 or T2 or T3 invasive adenocarcinoma of the prostate (any PSA, any Gleason score).
- •2. Males greater than 18 years old
- •3. Candidate for radical Intensity Modulated Radiotherapy.
- •4. ECOG performance status of 0 or 1.
- •5. Able to provide written informed consent, or consent can be provided by
- •authorized representative and approved by the appropriate Institutional
- •Review Board (IRB) of the respective clinical site.
- •6. Neo-adjuvant or adjuvant hormone therapy allowed
排除标准
- •1. Evidence of metastatic disease to the lymph nodes, bone or lung
- •2. Planned or previous pelvic or lymph node radiotherapy
- •3. Any other active malignancy (untreated, progressive or recurrent), except for
- •non-melanoma skin cancer.
- •4. Any inactive malignancy diagnosed within 5 years of entry, except for non- melanoma skin cancer.
- •5. Inflammatory bowel disease (active) such as Crohn’s disease and ulcerative colitis.
- •6. Active bleeding disorder.
- •7. Inflammatory bowel disease, chronic prostatitis or any urogenital anatomic
- •abnormality that would interfere with the ability to access the SpaceOAR® hydrogel injection site
研究者
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