A Phase II Trial of Hyperthermia and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Time of PSA Failure
研究概览
简要总结
Hyperthermia therapy may kill prostate cancer cells by heating them to several degrees above body temperature. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining hyperthermia with radiation therapy may kill more tumor cells.
The purpose of this study is to determine the ability of hyperthermia when combined with radiation therapy and in some patients hormonal therapy to control prostate cancer.
详细描述
The purpose of this study is to determine the ability of hyperthermia (heat treatments produced by sound waves) when combined with radiation therapy and in some patients hormonal therapy to control prostate cancer.
Hyperthermia refers to the use of temperatures 42 oC (107-6oF) or higher to treatment malignant tumors. Laboratory and some clinical reports have demonstrated a tumor killing effect if tumors are heated to 43oC (109oF) for 30-60 minutes.
Many studies have shown that hyperthermia improves the killing effect of radiation treatments for many tumors. In clinical studies, the addition of hyperthermia has shown to be beneficial for tumors of the breast, urinary bladder and the head and neck region with combined with radiation therapy. Investigators found an improvement in tumor response rates and a lengthened duration of response. The proposed study is one of the first controlled studies to attempt to prove the usefulness of hyperthermia for patients with prostate cancer.
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
- •Histologic confirmation of prostate cancer. (Slides will be obtained for central review)
- •Clinical stage T2b, T2c, T3a, or T3b disease as defined by the AJCC 4th edition staging manual (see Appendix A)
- •No evidence of metastatic disease (bone, lymph node or visceral) based on bone scan and computed tomography
- •Adequate hematologic function
- •WBC> 4000/mm3
- •platelet count > 100, 000/mm3
- •hematocrit of > 30%
- •An ECOG Performance Status of zero or one
- •A life expectancy of 5 years or more(excluding possible prostate related causes)
排除标准
- •Prior history of malignancy (except for non-melanoma skin cancer)
- •Prior systemic therapy
- •No prior chemotherapy
- •No prior hormonal therapy other than that recommended in this protocol
- •Prior pelvic radiotherapy
- •Medical problems (such as an abnormal bleeding propensity) which would make transrectal ultrasound-directed transperineal thermal probe placement hazardous.
- •Patients with severe insulin-dependent diabetes mellitus and evidence of neuropathy or vaculopathy
- •Patients with unstable cardiac status including:
- •Unstable angina pectoris on medication
- •Patients with documented myocardial infarction within six months of protocol entry
- •Congestive heart failure requiring medication
- •Patients on anti-arrhythmic drugs
- •Severe hypertension (diastolic BP> 100 on medication
- •Patients with cardiac pacemakers
- •Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- •Severe COPD (medication requiring, with FEV 1 < 50% of expected or < 1 liter)
- •Individuals who appear unlikely to tolerate the required prolonged stationary position during treatment due to emotional immaturity or instability or otherwise due to mental incompetence.
研究组 & 干预措施
Hyperthermia
XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)
干预措施: Hyperthermia (Device)
Hyperthermia
XRT and Hyperthermia Post-therapy evaluation PSA, Clinical Exam, and Prostate Biopsy ( @ 12 Months)
干预措施: XRT (Radiation)
结局指标
主要结局
Time of PSA Failure
时间窗: 2 Years
Kaplan Meier estimation and Cox regression model
次要结局
- Local Control and Disease Specific survival(One year post treatment)
研究者
Irving Kaplan
Principal Investigator
Dana-Farber Cancer Institute