Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 186
- 试验地点
- 6
- 主要终点
- Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
研究概览
简要总结
This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. 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 assess the gastrointestinal (GI) and genitourinary (GU) toxicities in patients treated with hypo-fractionated postoperative radiotherapy relative to the conventional postoperative radiotherapy.
SECONDARY OBJECTIVES:
I. To report patient outcome to include local control, loco-regional control, distant metastases, biochemical progression-free survival, prostate-cancer specific survival (PCSS), time to salvage therapy.
Ia. To compare freedom from biochemical failure (FFBF) and time to progression (TTP) with definition of post prostatectomy nadir + 2 ng/mL in both treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Men age 18 or older
- •Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
- •Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
- •For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of >= 0.
- •PSA >= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
- •Patient diagnosed with Gleason score of 6-10
- •Eastern Cooperative Oncology Group (ECOG) performance 0-2
- •Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
- •If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer
排除标准
- •Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
- •Neoadjuvant chemotherapy before or after prostatectomy
- •History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
- •History of severe active co-morbidity or uncontrolled diabetes
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
- •End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
研究组 & 干预措施
Arm I (conventional radiation therapy)
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
干预措施: Quality-of-Life Assessment (Other)
Arm I (conventional radiation therapy)
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
干预措施: Questionnaire Administration (Other)
Arm I (conventional radiation therapy)
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
干预措施: Radiation Therapy (Radiation)
Arm II (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Arm II (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
干预措施: Quality-of-Life Assessment (Other)
Arm II (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
时间窗: At 2 years
Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.
次要结局
- Loco-regional control(Up to 5 years)
- Biochemical failure (FFBF)(Up to 5 years)
- Patient reported quality of life outcomes(Up to 5 years)
- Health economics(Up to 5 years)
- Local control(Up to 5 years)
- Prostate-cancer specific survival (PCSS)(Up to 5 years)
- Time to salvage therapy(Up to 5 years)
- Patient reported GI symptoms(At end of RT, 6, 12, 24, and up to 60 months from the end of RT)
- Distant metastases(Up to 5 years)
- Biochemical progression-free survival(Up to 5 years)
- Time to progression (TTP)(Up to 5 years)
- Patient reported GU symptoms(At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT)