A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 170
- 主要终点
- 5-Year Freedom From Progression Rate
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
详细描述
OBJECTIVES:
- Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
- Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
- Compare morbidity and quality of life of patients treated with these regimens.
- Determine the feasibility of collecting Medicare data in a large Radiation Therapy Oncology Group (RTOG) prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
- Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
- Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.
After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •T1c-T2b, N0, M0
- •Intermediate-risk disease, as defined by 1 of the following:
- •Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
- •Gleason score 7 AND PSA < 10 ng/mL
- •No evidence of distant metastases
- •Prostate volume ≤ 60 cc by transrectal ultrasonography
- •American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Patients must use effective contraception
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
- •No major medical or psychiatric illness that would preclude study therapy
- •No hip prosthesis
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Prior neoadjuvant hormonal therapy allowed provided the following are true:
- •Therapy was initiated within 2-6 months of study enrollment
- •Therapy was no more than 6 months in duration
- •Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
- •No concurrent hormonal therapy
- •Radiotherapy
- •No prior pelvic radiotherapy
- •No prior radical surgery for prostate cancer
- •No prior transurethral resection of the prostate
- •No prior cryosurgery
- •No prior transurethral needle ablation of the prostate
- •No prior transurethral microwave thermotherapy of the prostate
排除标准
- 未提供
研究组 & 干预措施
EBRT + Brachytherapy
External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
干预措施: Brachytherapy (100/110) (Radiation)
EBRT + Brachytherapy
External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
干预措施: External Beam Radiation Therapy (Radiation)
Brachytherapy Only
Transperineal interstitial permanent brachytherapy (125/145)
干预措施: Brachytherapy (125/145) (Radiation)
结局指标
主要结局
5-Year Freedom From Progression Rate
时间窗: From randomization to 5 years
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
次要结局
- Biochemical Failure Rate (Protocol Definition)(From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.)
- Distant Metastases(From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.)
- Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall](From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years.)
- Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months(Baseline and 24 months after start of radiation)
- Local Failure(From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.)
- Overall Survival(From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years.)
- Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall](Zero to 180 days from the start of radiation)
- Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months(Baseline and 24 months after start of radiation)
- Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months(Baseline and 4 months after start of radiation)
- Biochemical Failure (Phoenix Definition)(From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.)
- Prostate Cancer Death(From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.)
- Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months(Baseline and 4 months after start of radiation)
- Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months(Baseline and 24 months after start of radiation)
- Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months(Baseline and 4 months after start of radiation)