Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).
研究概览
简要总结
There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.
详细描述
This will be a two cohort Phase II single center, prospective trial, with a safety lead-in component. This design will allow an initial toxicity assessment phase of a novel radiation treatment schema that is based on other literature, but with limited evidence. There is no plan to escalate the dose. Pending assessment of the safety lead in, complete enrollment will be permitted. Each cohort will be analyzed separated for the safety lead in. There will be 7 patients in the safety lead in cohorts. The stopping point will be an incidence of 2 cases of CTCAE v5.0 Grade 3+ acute toxicity attributed to therapy within gastrointestinal or urinary domains. This generally entails symptoms significant enough to require a procedure or limit basic levels of daily activity (bathing, cooking). Actue toxicity of a comparable magnitude has been reported in the 1-5% rate in a recent meta-analysis of contemporary trials which utilized standard of care radiation. Thus two cases would represent an unacceptable increased toxicity level, and a cohort size of 7 is approximate the commonly accepted size in Phase I escalation studies to evaluate dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adenocarcinoma of the prostate with previous surgical resection
- •Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation
- •Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field
- •At least two serum detectable PSA levels defined as >0.02 ng/dl at least 30 days apart.
排除标准
- •Metastatic disease
- •Prior radiation therapy to the pelvis region
- •Inflammatory bowel disease
- •Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months
- •Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months
- •PSA >10 ng/dl at study entry,
结局指标
主要结局
The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).
时间窗: 5 years
We will utilize a globally standard definition of bPFS which was defined in the RADICALS(6) international trial as follows: freedom from PSA of 0·4 ng/mL or greater following postoperative radiotherapy, or PSA of more than 2·0 ng/mL at any time following therapy, clinical progression, or initiation of non-protocol hormone therapy, or death from any cause.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
时间窗: 1-2 years
The Primary objective of the safety lead in component is to report acute, attributable genitourinary and gastrointestinal toxicity as scored by CTCAE v5.0.
次要结局
- Long term side effects(5 years)
- Need for long term anti-testosterone therapy(5 years)
- Distant metastasis free survival(5 years)
研究者
Michael Cummings
Michael Andrew Cummings, M.D., Assistant Professor of Radiation Oncology
University of Rochester