A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 6
- 主要终点
- To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
研究概览
简要总结
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.
详细描述
Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.
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
- 是
入选标准
- •Histologically determined adenocarcinoma is required.
- •All other histologies are excluded.
- •Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
- •Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to
- •2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M
- •N0 stage may be assigned following either negative imaging or negative pathologic assessment.
- •Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.
- •PSA must be less than 20 ng/ml. ,
- •Age ≥ 18,
- •IPSS voiding symptoms score must be less than 18,
- •Study consent form must be signed by the patient.
排除标准
- •Gleason score of 8 - 10,
- •Clinical stage T3 - T4,
- •Age ≤ 18,
- •Any evidence of nodal (N1) or distant (M1) disease,
- •Prostate volume as assessed by TRUS > 60 cc,
- •PSA > 20 ng/ml,
- •IPSS voiding symptoms score > 18,
- •Prior TURP,
- •Prior pelvic radiotherapy or chemotherapy,
- •Prior prostatectomy,
- •Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years,
- •Current medical or psychiatric illness that may interfere with treatment completion and followup,
- •Hip prosthesis,
- •Unable or unwilling to give informed consent
结局指标
主要结局
To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
时间窗: Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.
At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.
次要结局
未报告次要终点