NCT00585962已完成2 期
A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
研究概览
简要总结
The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.
详细描述
- Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
- Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than
- •PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
- •Zubrod status 0-
- •No evidence of distant metastasis.
- •No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.
排除标准
- •Clinical stages T2c or above.
- •PSA greater than
- •Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than
- •Evidence of lymph node involvement if lymph node sampling performed.
- •Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
- •Previous prostate radiation.
- •Prior hormonal therapy.
- •History of inflammatory bowel disease even if currently inactive or controlled on medication.
- •Prior systemic chemotherapy.
- •History of proximal urethral stricture requiring dilatation.
- •Current and continuing anticoagulation with Coumadin or equivalent.
- •Major medical or psychiatric illness
结局指标
主要结局
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
时间窗: 3 years
次要结局
- To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.(3 years)
研究者
Anthony Laurence Zietman, MD
Principal Investigator
Massachusetts General Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic MetastasesHepatocellular CancerHepatic MetastasesCholangiocarcinomaNCT00465023Massachusetts General Hospital16
已完成
不适用
Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and CholangiocarcinomaLiver CancerNCT00976898Massachusetts General Hospital83
撤回
2 期
Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph NodesStage IB Cervical CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage IVA Cervical CancerCervical CancerNCT01019278Abramson Cancer Center at Penn Medicine
已完成
不适用
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate CancerProstate CancerNCT01040624University of Florida77
已完成
不适用
Proton Radiation Therapy (RT) for the Treatment of Pediatric RhabdomyosarcomaRhabdomyosarcomaNCT00592592Massachusetts General Hospital115