Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of grade 2 or greater genitourinary adverse events (AEs)
研究概览
简要总结
This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity.
SECONDARY OBJECTIVES:
I. Prostate specific antigen (PSA) response at 6 weeks after radiation therapy (RT), every 3 months for 24 months, every 6 months to 60 months, then every 8-12 months until 5 years.
II. Clinical progression free survival/biochemical progression free survival at 5 years.
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
- 40 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
- •Multiparametric MRI (mp-MRI) confirmed lesion(s)
- •No distant or locally advanced disease on standard staging exams as indicated
- •Bone scan and abdominopelvic computed tomography (CT)/MRI OR
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
排除标准
- •Radiographic nodal or distant metastatic disease
- •Lesion(s) comprising > 40% of total prostate volume
- •Prior radiotherapy to the pelvis
- •Gleason score > 6 disease outside intended gross target volume (GTV)/target region(s)
研究组 & 干预措施
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: Biopsy Procedure (Procedure)
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: High-Dose Rate Brachytherapy (Radiation)
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: Multiparametric Magnetic Resonance Imaging (Procedure)
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: PSMA PET Scan (Procedure)
Treatment (HDR-BT)
Patients undergo HDR-BT to dominant prostate lesion on day 1. Treatment repeats at least 3 weeks apart for up to 2 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, mpMRI and optionally PSMA PET throughout the study. Additionally, patients may undergo tumor biopsy as clinically indicated throughout the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of grade 2 or greater genitourinary adverse events (AEs)
时间窗: Up to 6 years
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be calculated to indicate the toxicity level of focal radiation therapy (RT), along with the corresponding 95% Clopper-Pearson exact confidence interval.
Incidence of grade 2 or greater gastrointestinal AEs
时间窗: Up to 6 years
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using CTCAE v 5.0. Will be calculated to indicate the toxicity level of focal RT, along with the corresponding 95% Clopper-Pearson exact confidence interval.
Time to first grade 2 or greater adverse event
时间窗: Up to 6 years
Will be analyzed as a time-to-event outcome using Kaplan-Meier (KM) methods.
Local control rate
时间窗: Up to 6 years
Will be defined as lack of biopsy proven progression within target/treated region/lesion. The proportion of patients achieving local control will be estimated along with the corresponding 95% Clopper-Pearson exact confidence interval.
次要结局
- Patient reported quality of life(Up to 6 years)
- Prostate specific antigen (PSA) response(At 3, 6, 12 and 24 months)
- Biochemical progression free survival(Up to 5 years)
- Clinical progression free survival(Up to 5 years)
- Distant metastasis free survival(Up to 5 years)
- Overall survival(Up to 6 years)
- Expanded Prostate Cancer Index Composite Short Form questionnaire score(Up to 6 years)