A Phase II Study of Targeted Brachytherapy for Low Risk Prostate Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Biochemical PSA control using the Phoenix definition of PSA nadir + 2
研究概览
简要总结
This phase II trial studies how well internal radiation therapy works in treating patients with low-risk prostate cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine long term 5 year prostate specific cancer (PSA) biochemical control using the Phoenix definition of PSA nadir + 2 of targeted hemi-gland brachytherapy.
SECONDARY OBJECTIVES:
I. To assess acute and late toxicity outcomes following targeted brachytherapy according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
II. To determine changes from baseline in health-related quality of life indicators using the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire, International Index of Erectile Function (IIEF) questionnaire, and International Prostate Symptom Score (IPSS) questionnaire.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- •Unilateral prostate cancer as determined by prostate biopsy
- •Less than or equal to 3 positive biopsy cores
- •No biopsy core >= 50% positive for cancer
- •Karnofsky performance status (KPS) >= 70
- •At least a 12 core prostate biopsy; if this was not performed then it will be repeated here at University of California at Los Angeles (UCLA)
- •Artemis guided biopsy of any suspicious target lesions as identified on multiparametric (mp)-magnetic resonance imaging (MRI)
- •Clinical stage T1c or T2a
- •PSA < 10 ng/ml
- •Gleason score 3+3=6
排除标准
- •Patients who have previously received radiation therapy to the pelvis
- •Refusal to sign the informed consent
- •Patients who are participating in a concurrent treatment protocol
研究组 & 干预措施
Treatment (image-guided HDR brachytherapy)
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
干预措施: brachytherapy (Radiation)
Treatment (image-guided HDR brachytherapy)
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
干预措施: image-guided radiation therapy (Radiation)
Treatment (image-guided HDR brachytherapy)
Patients undergo 3 fractions of image-guided HDR brachytherapy over 2 days.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Biochemical PSA control using the Phoenix definition of PSA nadir + 2
时间窗: 5 years
次要结局
- Changes in HR-QOL as determined by IPSS scores(Up to 24 months)
- Grade 3-5 acute toxicity genitourinary (GU) and gastrointestinal (GI) toxicity, graded based on NCI CTCAE v4.0(3 months)
- Grade 3-5 late toxicity GU and GI toxicity, graded based on NCI CTCAE v4.0(6 months)
- Changes in health related quality of life (HR-QOL) as determined by EPIC scores(Up to 24 months)
- Changes in HR-QOL as determined by IIEF scores(Up to 24 months)