NCT00621413撤回不适用
Dosimetric and Morbidity Outcomes of Cs-131 Brachytherapy in Combination With External Beam Radiation Therapy in Subjects With Intermediate to High Risk Adenocarcinoma of the Prostate: An Observational Study
IsoRay Medical, Inc.9 个研究点 分布在 1 个国家开始时间: 2007年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 9
- 主要终点
- The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate.
研究概览
简要总结
The purpose of this study is to observe PSA response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with Cesium-131 in combination of external beam therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinical stage T1c - T2c (AJCC 6th Edition), NX/N0, M0
- •Karnofsky Performance Score of 90 to 100
- •Greater than or equal to 18 years of age
- •Prostate volumes by TRUS ≤ 60 cc
- •I-PSS score < 15 (alpha blockers allowed)
- •Signed study-specific informed consent form prior to study entry
- •Intermediate Risk prostate cancer as determined by the following:
- •Gleason sum of 7; PSA less than 10.1 ng/ml; Stage T2a or less
- •Gleason sum 6 or less; PSA >10.0 and < 20.1ng/ml; Stage T2a or less
- •Gleason sum 6 or less; PSA < 10.1; Stage T2b
- •High risk prostate cancer as determined by the following:
- •Any Gleason Sum; PSA greater than 20 ng/ml; Stage T2c or less
- •Gleason Sum > 7; Any PSA; Stage T2c or less
- •Any Gleason Sum; Any PSA; Stage T2c
- •Any two or three intermediate risk factor
排除标准
- •Lymph node involvement (N1)
- •Evidence of distant metastases (M1)
- •Any hormonal blockade or therapy that:
- •Has persisted for more than 6 months by time of protocol screening; OR
- •Is ongoing within 3 months of study enrollment
- •Radical surgery for carcinoma of the prostate
- •Prior pelvic radiation
- •Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years
- •Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up
- •Hip prosthesis
- •Inability or refusal to provide informed consent
结局指标
主要结局
The analysis of dosimetric data resultant from Cs-131 permanent prostate brachytherapy in combination with external beam radiation therapy in the setting of intermediate to high risk cancer of the prostate.
时间窗: 5 years
Data collected for analysis will be total therapeutic dose delivered to the prostate by the Cs-131 brachytherapy implant treatment in units of Gy.
次要结局
- The analysis of treatment related morbidities following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.(5 years)
- The analysis of PSA control rates following Cs-131 prostate brachytherapy in combination with external beam therapy for intermediate to high risk cancer of the prostate.(5 years)
研究者
研究点 (9)
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