Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Erectile Dysfunction - Change from baseline
研究概览
简要总结
This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥18 years of age
- •Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR-
- •Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20)
- •Life expectancy >10 yrs
- •Physically and mentally capable of signing the consent form of their own volition
排除标准
- •< 18 years of age
- •Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20)
- •Current or historical use of androgen deprivation therapy
- •Nodal positivity
- •Previous cancer excluding non-melanoma skin cancer
- •History of prostatectomy
- •History of brachytherapy for prostate cancer
- •Life expectancy <10 yrs
- •Physically or mentally incapable of signing the consent form of their own volition
研究组 & 干预措施
Prospective Treatment Group
Proton Boost
干预措施: Proton Boost (Radiation)
Retrospective Comparison Group
Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only.
结局指标
主要结局
Erectile Dysfunction - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe)
Urinary Incontinence - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe)
Hematuria - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe)
Dysuria - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Presence or Absence
International Prostate Symptom Score - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms
Rectal Bleeding - Change from baseline
时间窗: Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years
Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe)
次要结局
- Progression Free Survival(Monitored for 10 years after completion of radiation therapy)
- Overall Survival(Monitored for 10 years after completion of radiation therapy)
研究者
William Barrett
Director, University of Cincinnati Cancer Institute Medical Director, Charles M. Barrett Cancer Center Professor and Chairman, Radiation Oncology University of Cincinnati
University of Cincinnati