Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 36
- 主要终点
- Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
研究概览
简要总结
The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.
详细描述
In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (HDR) brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues.
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
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
- •Patient must be at least 18 years of age
- •Histologically proven prostate adenocarcinoma
- •Biopsy within 1 year of date of registration
- •Clinical Stage (CS) T1b-T2b, N0, M0
- •Patients belonging to one of the following risk categories:
- •Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (PSA) < or = 10 ng/ml
- •Intermediate Risk: CS T2b, Gleason Score 2-6, PSA < or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA < or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA < or = 10 ng/ml
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
排除标准
- •Clinical Stage T2c or greater
- •Prior prostatectomy or cryotherapy of the prostate
- •Prior radiotherapy of the prostate or lower pelvis
- •Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
- •History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
- •Hormone ablation for two months prior to enrollment or during treatment
结局指标
主要结局
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
时间窗: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed in both low-risk and intermediate-risk cohorts during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Biochemical Disease-Free Survival (bDFS)
时间窗: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.
次要结局
- Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)(AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Disease Control and Survival Outcomes(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Bowel(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)
- Quality of Life Assessments: EPIC-26 Sexual(Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.)