Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Acute Toxicities
研究概览
简要总结
Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.
详细描述
Pre-Treatment:
Planning CT and mpMRI imaging for SABR TRUS with biopsy and insertion of Gold Seed Fiducial Markers Biobanking of urine, blood and biopsy tissue (as per REB#079-2006 Odette Cancer Centre (OCC) biobanking protocol)
Stereotactic Ablative Body Radiation (SABR):
13.5Gy x 1 to whole prostate + 1cm seminal vesicles 2 weeks post-planning, treatment will be delivered as per standard treatment protocols on SABR-compatible linear accelerator with a six-degree of freedom couch. Cone-beam CT imaging will be performed using the implanted fiducials to set up each treatment. All dosimetric parameters will be recorded.
Inter-treatment (approx 1 week post-SABR):
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Favorable risk disease defined as either:
- •Low risk disease: T1-T2c, grade group 1, PSA < 10 ng/ml or
- •Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity > 50%
- •Prostate volume < 60 cc as determined by US, CT or MRI
- •Ability to undergo MR imaging
- •Provide written informed consent
排除标准
- •Documented nodal or distant metastases
- •Previous pelvic radiotherapy
- •Previous transurethral resection of prostate, previous prostatectomy or HIFU
- •Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors permitted
- •Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >15
- •Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- •Significant medical co-morbidity rendering patient unsuitable for general anaesthesia
结局指标
主要结局
Acute Toxicities
时间窗: 6 months
Acute GU and GI toxicities according to the NCI CTCAE v4.0
次要结局
- Late Toxicities(5 years)
- PSA(5 years)
- QOL(5 years)
研究者
Andrew Loblaw
GU Radiation Oncology Site Group Lead
Sunnybrook Health Sciences Centre