A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Freedom from failure (FF)
研究概览
简要总结
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
详细描述
PRIMARY OBJECTIVE:
I. To determine if stereotactic body radiation therapy (SBRT) would result in similar freedom from failure (FFF) than standard fractionation photon therapy.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events [CTCAE] version 4).
II. After completion of radiation therapy, determine the incidence of grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 4).
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
- 否
入选标准
- •Histologically confirmed prostate adenocarcinoma at the time of surgery
- •Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.])
- •One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0
- •PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
- •Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- •Patients must complete all required pre-entry tests within the specified time frames
- •Patients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registration
- •Members of all races and ethnic groups are eligible for this trial
- •Patients from outside of the United States may participate in the study
排除标准
- •Previous pelvic radiation
- •Prior androgen suppression therapy for prostate cancer for more than 6 months
- •Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- •Prior systemic chemotherapy for prostate cancer
- •History of proximal urethral stricture requiring dilatation
- •Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
- •Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
- •Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)
- •History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
研究组 & 干预措施
Group I (hypofractionated radiation therapy)
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Group I (hypofractionated radiation therapy)
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
干预措施: Quality-of-Life Assessment (Other)
Group I (hypofractionated radiation therapy)
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
干预措施: Questionnaire Administration (Other)
Group II (radiation therapy, androgen suppression therapy)
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
干预措施: Androgen Suppression (Drug)
Group II (radiation therapy, androgen suppression therapy)
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Group II (radiation therapy, androgen suppression therapy)
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
干预措施: Quality-of-Life Assessment (Other)
Group II (radiation therapy, androgen suppression therapy)
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
干预措施: Questionnaire Administration (Other)
Group III (radiation therapy, androgen suppression therapy)
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
干预措施: Androgen Suppression (Drug)
Group III (radiation therapy, androgen suppression therapy)
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Group III (radiation therapy, androgen suppression therapy)
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
干预措施: Quality-of-Life Assessment (Other)
Group III (radiation therapy, androgen suppression therapy)
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Freedom from failure (FF)
时间窗: Up to 5 years
Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA \>= 0.5 ng/ml).
次要结局
未报告次要终点