A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 37
- 主要终点
- Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells.
PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To demonstrate that 1-year health-related quality of life (HRQOL) for at least one hypofractionated arm is not significantly lower than baseline as measured by the Bowel and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.
Secondary
- To estimate the degree of change in HRQOL in each arm for the Sexual and Hormonal EPIC domains and the Utilization of Sexual Medications/Devices from baseline to 1 year, 2 years, and 5 years.
- To estimate the degree of change in global HRQOL in each arm as measured by the Euro Quality of Life, 5 dimensions (EQ-5D) from baseline to 1 year, 2 years, and 5 years.
- To estimate the rate of acute and late gastrointestinal (GI) and genitourinary (GU) toxicity for each arm at 1, 2, and 5 years.
- To estimate prostate-specific antigen (PSA) failure in each arm at 1, 2, and 5 years.
- To estimate disease-free survival (DFS) in each arm at 1, 2, and 5 years.
- To estimate Quality Adjusted Life Years for each arm at 1, 2, and 5 years using the EQ-5D and DFS.
- To identify genetic markers associated with normal tissue toxicities resulting from radiotherapy.
- To collect tumor tissue for biomarker studies.
- To estimate EPIC bowel and urinary HRQOL as continuous variables.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
- •History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
- •Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization
- •Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization
- •Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;
- •PSA should not be obtained within 10 days after prostate biopsy
- •No evidence of distant metastases
- •No regional lymph node involvement
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
- •No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
- •No severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- •Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
- •HIV testing is not required for entry into this protocol
- •Protocol-specific requirements may also exclude immuno-compromised patients
- •PRIOR CONCURRENT THERAPY:
- •No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer
- •No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
- •No finasteride within 30 days prior to registration
- •Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
- •No dutasteride within 90 days prior to registration
- •PSA should not be obtained prior to 90 days after stopping dutasteride
- •No prior or concurrent cytotoxic chemotherapy for prostate cancer
- •Patients on Coumadin or other blood-thinning agents are eligible for this study
- •No concurrent 3D-conformal radiation therapy
排除标准
- 未提供
研究组 & 干预措施
5 Fractions
36.25 Gy IMRT in 5 fractions over two and a half weeks
干预措施: 36.25 Gy IMRT (Radiation)
12 Fractions
51.6 Gy IMRT in 12 fractions over two and a half weeks
干预措施: 51.6 Gy IMRT (Radiation)
结局指标
主要结局
Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points
时间窗: Baseline and one year from the end of protocol treatment
The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year \> 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points
时间窗: Baseline and one year from the end of protocol treatment
The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year \> 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.
次要结局
- Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm(Start of protocol treatment to one year from the end of protocol treatment)
- Rate of PSA Failure(Registration to five years)
- Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy(Study entry to 5 years from the end of protocol treatment)
- The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points(Baseline one year from the end of protocol treatment)
- The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points(Baseline and one year from the end of protocol treatment)
- Change From Baseline in EQ-5D Scores(Baseline and one year from the end of protocol treatment)
- Mean Quality Adjusted Life Years at 5 Years(Registration to 5 years from the end of protocol treatment)
- Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year(Baseline and one year from the end of protocol treatment)
- Rate of Disease-free Survival (DFS)(Registration to 5 years)
- Utilization of Sexual Medications/Devices Questionnaire Response Frequences(Baseline and one year from the end of protocol treatment)