A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 36
- 主要终点
- overall survival
研究概览
简要总结
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
详细描述
OBJECTIVES:
- Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
- Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
- Compare the side effects of these treatment regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radical prostatectomy.
- Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
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
- — 至 75 Years（Child, 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 within the past 120 days
- •T1c-T2a, N0, M0
- •No bilateral disease
- •Prostate-specific antigen (PSA) no greater than 10 ng/mL
- •In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy
- •Gleason score no greater than 6
- •Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR
- •Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •ECOG 0-2 OR
- •Zubrod 0-2
- •Creatinine no greater than 3 mg/dL
- •Cardiovascular:
- •No significant cardiovascular disease
- •No New York Heart Association class III or IV heart disease
- •No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
- •No other condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 90 days since prior NHT
- •Duration of therapy no greater than 120 days
- •No concurrent NHT
- •Radiotherapy:
- •No prior radiotherapy to pelvis
- •No prior surgery for prostate cancer or benign disease, including:
- •Transurethral resection of the prostate
- •Transurethral resection of the bladder neck
- •Cryotherapy
- •Laser ablation
- •Microwave therapy
排除标准
- 未提供
研究组 & 干预措施
surgery
Patients undergo radical prostatectomy.
Patients are followed every 6 months for 5 years and then annually thereafter.
干预措施: surgery (Procedure)
radiation
Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 6 months for 5 years and then annually thereafter.
干预措施: radiation (Radiation)
结局指标
主要结局
overall survival
时间窗: Up to 10 years
次要结局
- disease free survival(Up to 10 years)