NCT02572284已完成1 期
A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.
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
- •Histologically-proven prostate adenocarcinoma.
- •Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
- •Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
- •Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA >20 ng/mL.
- •Prostate volume: ≤ 80 cc on transrectal ultrasound
- •IPSS score ≤15
- •Zubrod performance status 0-2 or equivalent
- •No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
- •No prior radiotherapy to the prostate or lower pelvis
- •No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
- •No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 5 years
- •No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
- •Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
- •Ability to understand and the willingness to sign a written informed consent document
- •Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
- •Age ≥18 years
- •IPSS (AUA) score ≤15
排除标准
- •Does not have a diagnosis of prostate adenocarcinoma
- •Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
- •Has stage N1 or M1 (metastatic) disease
- •Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
- •Prostate volume greater than 80 cc on transrectal ultrasound
- •Zubrod performance status 3 or greater
- •Prior total prostatectomy or cryotherapy of the prostate
- •Prior radiation therapy to the pelvis
- •Implanted hardware which limits treatment planning or delivery (determined by the investigator).
- •Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
- •The use of androgen deprivation therapy (ADT) prior to registration or during radiation
- •Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
- •Unwilling or inability to give informed consent
- •Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
- •IPSS score >15
结局指标
主要结局
Dose Limiting Toxicity
时间窗: Up to 28 ± 5 days post-prostatectomy
Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of ≥3 is considered dose-limiting.
次要结局
- Mean Hospital Stay for Study Participants(Up to 18 months post surgery)
- Reoperation Rate for Study Participants(Up to 18 months post surgery)
- Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS)(Up to 18 months post surgery)
- Occurrence of Late Toxicity(90+ days after start of radiotherapy)
- Mean Catheterization Time for Study Participants(Up to 18 months post surgery)
- Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)(Up to 18 months post surgery)
- Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS)(Up to 18 months post surgery)
- Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM)(Up to 18 months post surgery)
研究者
研究点 (2)
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