Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
- •Pathologically-proven diagnosis of prostate adenocarcinoma
- •PSA 10-20ng/mL or
- •Gleason =7 or
- •Clinical stage T2b/c
- •Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
- •Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
- •International Prostate Symptom Score ≤15
排除标准
- •Prior prostate surgery (including TURP)
- •Prior history of chronic prostatitis or urethral stricture
- •Inflammatory bowel disease
- •Prior history of pelvic radiotherapy
- •Unable to give informed consent
- •Metastatic disease.
研究组 & 干预措施
radiation therapy in combination with brachytherapy
Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
干预措施: questionnaires (Behavioral)
radiation therapy in combination with brachytherapy
Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
干预措施: external beam radiation therapy (Radiation)
radiation therapy in combination with brachytherapy
Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
干预措施: brachytherapy (Radiation)
结局指标
主要结局
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
时间窗: 12 months
Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.
次要结局
- Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months(12 months)