NCT01098331终止不适用
Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients consenting to the treatment randomization
研究概览
简要总结
RATIONALE: Receiving standard information and watching a video or DVD at home that describes treatment options and treatment outcomes may help patients decide to receive treatment in a clinical trial.
PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well it works compared with surgery in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the proportion of patients consenting to the treatment randomization of brachytherapy vs radical prostatectomy in treating patients with good-risk prostate cancer.
- Determine the feasibility of randomization, in terms of average accrual rate per center, during the last 6 months of recruitment.
Secondary
- Determine the decisional quality post-treatment in these patients.
- Determine the compliance with allocated treatment in these patients.
- Determine the clinical failure in these patients.
- Determine the PSA relapse in these patients.
- Determine the patient-reported quality of life.
- Compare the toxicity of these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Meeting 1 of the following criteria:
- •Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA < 15 ng/mL
- •Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Life expectancy > 10 years (Decision-Aid Randomization)
- •Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial
- •No unacceptable risk for radical prostatectomy or prostate brachytherapy
- •INR < 1.5
- •No severe lower urinary tract symptoms
- •No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second, and/or post micturition bladder volume > 100 mL)
- •No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial
- •No other active malignancy likely to interfere with subsequent protocol treatment and follow-up
- •PRIOR CONCURRENT THERAPY:
- •No prior pelvic radiotherapy
- •No prior abdominoperineal (AP) rectal excision
- •No prior standard transurethral resection of prostate
- •No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)
- •At least 5 days since prior aspirin or clopidogrel
- •No concurrent warfarin
排除标准
- 未提供
研究组 & 干预措施
Arm Rx1: Radical Prostatectomy
Other
Arm Rx1: Radical Prostatectomy
干预措施: Radical Prostatectomy (Procedure)
Arm Rx2: Brachytherapy
Other
Arm Rx2: Brachytherapy
干预措施: Brachytherapy (Procedure)
结局指标
主要结局
Proportion of patients consenting to the treatment randomization
时间窗: 6 months
Feasibility of randomization in terms of average accrual rate per center during the last 6 months of recruitment
时间窗: 6 months
次要结局
- Compliance with allocated treatment(6 months)
研究者
研究点 (1)
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