A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
研究概览
简要总结
The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy [SBRT]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).
详细描述
Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy [SBRT]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA ≥ 0.1 ng/mL
- •Interval between prostatectomy and planned radiation therapy start date ≥ 6 months
- •Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy)
- •Ability to complete the EPIC-26 quality of life questionnaire
- •Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Prior history of pelvic radiation therapy
- •History of moderate/severe or active Crohn's disease or ulcerative colitis
- •History of bladder neck or urethral stricture
- •Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
- •Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
- •History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
- •Any condition that in the opinion of the investigator would preclude participation in this study
研究组 & 干预措施
Moderately Hypo-fractionated Radiation Therapy
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
干预措施: Moderately Hypo-fractionated Radiation Therapy (Radiation)
Ultra-Hypofractionated Radiation Therapy
5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks
干预措施: Ultra-hypofractionated radiation therapy (Radiation)
结局指标
主要结局
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
时间窗: 2-years post-treatment
GI and GU QOL assessed with the EPIC-26 questionnaire, bowel and urinary domains. Change scores will be calculated as baseline score subtracted from 2-year score. All patients with EPIC bowel and urinary domain scores will be included in the primary endpoint analysis. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score \>96, low bowel score \<= 96, high urinary score \> 84, low urinary score \<=84.
次要结局
- Patient reported GI quality of life (QOL) up to 60 months(60 months post-treatment)
- Time to progression(up to 5 years)
- Rate of biochemical failure(up to 5 years)
- Patient reported GU quality of life (QOL) up to 60 months(60 months post-treatment)
- Treatment related toxicity - acute(≤ 90 days after treatment completion)
- Treatment related toxicity - late(>90 days after treatment completion, up to 5 years)
- Overall survival(up to 5 years)
- Local failure, Regional failure, Distant metastases(up to 5 years)
- Prostate cancer specific survival(up to 5 years)