Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Toxicity Rates
研究概览
简要总结
The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.
详细描述
This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative to standard of care. Data does not yet exist for the safety and efficacy of this regimen.
However, the feasibility of ultra-short radiation therapy treatments has already been demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR brachytherapy has been adopted at high volume cancers centers as a standard treatment for prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to other treatment modalities.
Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses, but target volume coverage and urethral dose was not significantly different. These data suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible, efficacious and tolerable.
Eligible patients include all patients who are otherwise eligible for standard 5 fraction SBRT prostate. Study population will be low and intermediate patients with good urinary function (as defined by small prostate volume and low IPSS score). SBRT treatment will be delivered to the prostate to 12.5 Gy x 2 fractions.
Hormonal therapy is permitted on this study. Permitted agents include: leuprolide (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon).
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
- •Ability of participant to sign a written informed consent.
- •Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA < 20
- •IPSS score < 15 (and < 10 if on medication for benign prostatic hypertrophy such as tamsulosin) at time of enrollment (Appendix 21.4)
- •Prostate volume (by US, CT or MRI measurement) < 50 cc at time of enrollment
- •Androgen deprivation therapy based on clinician judgment is permitted on study
- •Life expectancy > 10 years based on clinician's judgment
- •No other active malignancy
- •Age ≥ 18 years
- •Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 (Appendix 21.5).
- •Other study-specific criteria:
- •Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment.
- •NOTE: Acceptable forms of birth control are listed below:
- •One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS
- •Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).
排除标准
- •Current or anticipated use of other investigational agents while participating in this study.
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Prior pelvic radiation therapy
- •Prior prostatectomy
- •Inflammatory bowel disease or connective tissue disease requiring medical management
结局指标
主要结局
Toxicity Rates
时间窗: up to 5 year post radiation
Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients
次要结局
- Financial Toxicity Measurement(3 months, 6 months, and 12 month visits only)
- Biochemical Control Rate(1 month post-Radiation Therapy (RT), every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years)
- Radiation Therapy Oncology Group (RTOG) Late Toxicity Rate(3 year)
- RTOG Acute Toxicity Rate(90 days)
- Oxidative stress as a predictor of toxicity(1 month post-RT, every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years)
研究者
Xinglei Shen
Medical Doctor
University of Kansas Medical Center