Focal Radiation Therapy (FRaT) Trial in Patients With Low/Intermediate-Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Biochemical progression free survival
研究概览
简要总结
This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate biochemical progression free survival (bPFS) using the Phoenix definition.
II. Changes in quality of life. IIa. Prostate-Quality of Life (PR-QOL). IIb. Expanded Prostate Cancer Index Composite (EPIC).
SECONDARY OBJECTIVES:
I. Prostate-specific antigen (PSA) response at 3, 6, 12, and 24 months. II. Clinical progression free survival. IIa. Including phoenix definition, local progression by Response Evaluation Criteria in Solid Tumors (RECIST), regional progression, distant metastasis, or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy and with the following low/intermediate-risk features:
- •cT1c - T2b
- •PSA =< 15
- •< 50% cores positive
- •Gleason score (GS) =< 7 (3+4 and 4+3 included)
- •Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with only one lobe involvement of the prostate
- •Unilateral disease on systematic biopsy
- •No distant or locally advanced disease on standard staging exams as indicated
- •Bone scan and abdominopelvic computed tomography (CT)/MRI OR
- •Prostate specific membrane antigen (PSMA) positron emission tomography (PET)
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
排除标准
- •Gleason score >= 8
- •Gross extracapsular extension
- •Seminal vesicle invasion
- •Radiographic nodal or distant metastatic disease
- •Androgen deprivation therapy within 90 days of enrollment
- •Lesion(s) comprising > 40% of total prostate volume
- •Lesion < 0.5 cm from urethra
- •Prior radical prostatectomy
- •Prior radiotherapy to the pelvis
结局指标
主要结局
Biochemical progression free survival
时间窗: At 5 years
Will be assessed using the Phoenix definition and obtained via Kaplan-Meier analysis to provide an overview of efficacy for focal radiation therapy.
Change in quality of life
时间窗: Baseline up to 120 months
Will be assessed using Prostate-Quality of Life and Expanded Prostate Cancer Index Composite. The change of the two scores will be assessed via two-sided paired t-test.
Incidence of adverse events
时间窗: Up to 120 months (10 years)
Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0. Will be defined as the percentage of patients who encounter adverse events and calculated to indicate the toxicity level of focal radiation therapy.
次要结局
- Distant metastasis free survival(At 5 years)
- Development of castration-resistant disease(Up to 120 months (10 years))
- Overall survival(At 5 years)
- Clinical progression free survival(At 5 years)
- Prostate-specific antigen (PSA) response(At 3, 6, 12, and 24 months)