HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- number of patients achieving biochemical control
研究概览
简要总结
Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life.
This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer. Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function.
This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age ≥ 18 years
- •ECOG performance status 0 - 2
- •Histological evidence of prostate adenocarcinoma
- •Low- and favorable intermediate-risk prostate cancer
- •Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
- •No contraindications to MRI
- •Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
- •Baseline IPSS <18
- •No TURP within the past 6 months, nor large TURP defect
- •Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
- •No previous pelvic and/or prostate EBRT and/or brachytherapy
- •No contraindications to general anesthesia, or spinal/epidural anesthesia
- •Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
- •No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
- •Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (except for patients where clinician determines benefit outweighs the risk of radiation)
- •Absence of latex allergy
- •No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy
排除标准
- 未提供
研究组 & 干预措施
Tumour visible on MRI
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
干预措施: targeted focal HDR brachytherapy (Radiation)
No tumour visible on MRI
Whole-gland HDR Brachytherapy
干预措施: Whole-gland HDR Brachytherapy (Radiation)
结局指标
主要结局
number of patients achieving biochemical control
时间窗: 2 yrs
次要结局
未报告次要终点