A Randomized Feasibility Trial of Stereotactic Body Radiotherapy Versus Conventional Fractionation With High Dose-rate (HDR) Brachytherapy Boost for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Treatment Feasibility
研究概览
简要总结
Random assignment between SBRT and conventionally fractionated boost following HDR brachytherapy for prostate cancer.
详细描述
Many treatment options exist for prostate cancer. One common treatment approach is to combine high-dose rate (HDR) brachytherapy (temporary insertion of radiation into the prostate) and external beam radiation. External beam radiation typically requires daily radiation treatment for three to five weeks. Improvements to radiation planning and delivery has allowed stereotactic body radiation therapy (SBRT) to be implemented in many types of cancer. SBRT has been implemented as a standard treatment option after HDR brachytherapy in response to the COVID pandemic. We are seeking to evaluate whether it is feasible to randomly assign men between SBRT (which will be five treatments of radiation or conventional radiation (3-5 weeks of daily treatment) following HDR brachytherapy
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
- •Age 18 or older
- •Informed consent for treatment and study participation completed
- •Pathologically proven diagnosis of prostate adenocarcinoma
- •ECOG Performance Status 0-2
- •No prior history of pelvic radiotherapy, brachytherapy, cryosurgery, HIFU, TURP or radical prostatectomy
排除标准
- •Presence of nodal or distant metastasis on staging MRI or CT Abdomen/Pelvis and Bone scan within 90 days of enrolment (CT/MRI/Bone Scan are only required if the clinical risk of metastatic disease is sufficient to warrant these scans)
- •Plan for adjuvant chemotherapy post-radiotherapy
- •Serious medical comorbidities or other contraindications to HDR brachytherapy
- •Presence of inflammatory bowel disease
- •Presence of connective tissue disorder seen as a contraindication to radiotherapy
- •Medically unfit for general/spinal anesthesia
- •Unable or unwilling to complete questionnaires
结局指标
主要结局
Treatment Feasibility
时间窗: 18mo - 2 years
The proportion of patients accepting of being randomized divided by the number of patients approached for the study.
次要结局
- Freedom From Local Failure(7 years)
- QOL(7 years)
- Treatment Toxicity(7 years)
- Overall Survival(7 years)
- ADT Free Survival(7 Years)
- Cancer Free Survival(7 years)
- Metastasis Free Survival(7 years)
- Cumulative biochemical failure(7 years)
- Freedom From Regional Failure(7 years)
- PSA nadir(6 years)
研究者
Dr. Gerard Morton
Radiation Oncologist
Sunnybrook Health Sciences Centre