Phase I Feasibility Trial of Preoperative Adjuvant Stereotactic Body Radiotherapy for Patients at High Risk of Local Failure After Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
研究概览
简要总结
This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.
详细描述
PRIMARY OBJECTIVES:
I. To assess feasibility of pre-operative stereotactic body radiotherapy (SBRT) in prostate cancer patients at high risk for recurrence after prostatectomy.
SECONDARY OBJECTIVES:
I. To assess safety and acute toxicity of SBRT followed by prostatectomy. This will be based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and patient reported quality of life (Expanded Prostate Cancer Index Composite [EPIC] and International Prostate Symptom Score [IPSS] questionnaires).
II. Investigation of the radiobiology of SBRT in prostate cancer using resected prostate tumor tissue.
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
- •Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
- •Patient desires and is medically fit to undergo prostatectomy
- •Karnofsky performance status (KPS) >= 70
- •Patients on androgen deprivation therapy (ADT) are allowed
- •For confirmation of high risk local failure status, patients will have any one of the following:
- •Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study
- •Pre-biopsy prostate-specific antigen (PSA) >= 20
- •Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy
- •Gleason score 7 and > 50% of biopsy cores positive for prostate cancer
- •Clinical stage >= T3 (staging by imaging acceptable)
- •An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy
排除标准
- •Distant metastases, based upon:
- •CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and
- •Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration
- •Patient is unable or unwilling to sign consent
- •Patient is considered low-risk and would not have received adjuvant radiation therapy (RT) outside of this study
结局指标
主要结局
Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications
时间窗: At 4 weeks post surgery
次要结局
- Changes in Quality of Life (QOL) ,From Baseline to 12 Months, as Measured on the Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Scoring.(score from baseline to twelve months)
- Changes in Quality of Life as Measured on the International Prostate Symptom Score (IPSS) Questionnaire.(Mean change in I-PSS score from baseline to 12 months.)
- Correlative Biomarker Analyses Using Tissue and Serial Blood Samples(Baseline and to up to 1 year)
- Number of Participants With Genitourinary Toxicities and Gastrointestinal Toxicities(Up to 1 year)