A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Measure of PSA (Prostate Specific Antigen)
研究概览
简要总结
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before 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 (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 +
- •No more than 1 lymph node >1 cm.
- •PSA ≤ 50 ng/ml, obtained within 3 months
- •Prostate volume: ≤60 cc.
- •IPSS score ≤
- •No previous radiotherapy to the prostate or lower pelvis.
- •Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
- •No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
- •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 3 years.
- •No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
- •Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Ability to understand and the willingness to sign a written informed consent document.
- •Willing to fill out quality of life questionnaires.
排除标准
- 未提供
研究组 & 干预措施
Stereotactic Body Radiation Therapy, followed by Prostatectomy
Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Device)
结局指标
主要结局
Measure of PSA (Prostate Specific Antigen)
时间窗: Up to 12 months
Measure of PSA through treatment. PSA is expected to be undetectable (\<0.2 mg/ml) after prostatectomy and radiation therapy.
Number of symptomatic adverse anastomotic events
时间窗: Up to 12 months
Number of symptomatic anastomotic events related to pre-operative SBRT.
次要结局
- Mean Catheterization Time(Up to 4 weeks post surgery)
- Mean Hospital Stay(Up to 2 week post surgery)
- Quality of Life assessment(Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery)