A Prospective Study of Lower Dose Radiation (LO-RADS) for Prostate Cancer Using MRI Dose Mapping to Preserve Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in bowel related quality of life
研究概览
简要总结
The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).
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
- •Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2
- •Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.
排除标准
- •Distant metastases
- •Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
- •Prior pelvic radiotherapy including brachytherapy.
- •Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
- •Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
- •Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate < 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
- •Patients for whom hydrogel or hyaluronic acid spacer will be placed.
- •Patients incapable of giving informed consent.
- •Patients who are unable to adhere to the experimental protocols for any reason.
研究组 & 干预措施
Radiation therapy
Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).
干预措施: Radiation (Radiation)
Radiation therapy
Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).
干预措施: MRI (Radiation)
Radiation therapy
Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).
干预措施: Androgen Deprivation Therapy (Other)
结局指标
主要结局
Improvement in bowel related quality of life
时间窗: 12 months after treatment
Decrease by at least 5 points in bowel related endpoints as measured by Expanded Prostate Cancer Index Composite 26 (EPIC-26) questionnaire.
次要结局
- Biochemical control(2 year after start of treatment)
- Patient reported quality of life(12 months post treatment)
- Relationship between Imaging findings and Pathologic (tissue) findings(12 months post treatment)
- Treatment Side effects(12 months post treatment)