The Role of Salvage Prostatectomy for Radiation Failure in Prostate Carcinoma: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 61
- 主要终点
- Survival characteristics
研究概览
简要总结
RATIONALE: Prostatectomy may be an effective treatment for prostate cancer that has not responded to radiation therapy.
PURPOSE: This phase II trial is studying how well prostatectomy works in treating patients with recurrent or persistent prostate cancer that has not responded to radiation therapy.
详细描述
OBJECTIVES:
- Determine the characteristics of failure-free survival, disease-free survival, overall survival, surgical morbidity and mortality, and quality of life of patients treated with salvage prostatectomy for the recurrence of persistent disease after treatment with prior radiotherapy for localized prostate cancer.
- Develop expertise in the use of salvage prostatectomy prior to a possible phase III trial of salvage prostatectomy in this population versus a control arm such as hormonal therapy or cryotherapy.
- Determine the quality of life measures in these patients.
- Determine the preliminary data on the quality of life of patients undergoing salvage radical prostatectomy and use the data to design a phase III study.
- Determine the histologic and morphometric characterization of the carcinoma.
OUTLINE: Patients undergo modified bilateral pelvic lymph node dissection.
Patients with negative nodes undergo salvage prostatectomy via either retropubic or perineal approach. Patients with positive nodes may undergo radical prostatectomy at the discretion of the investigator.
Postoperative hormonal therapy may be given at time of symptomatic disease progression or a newly positive bone scan, or for a consistently rising prostate-specific antigen. Adjuvant hormonal therapy is also allowed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 proven recurrent or persistent prostate cancer
- •Prostate-specific antigen (PSA) no greater than 20 ng/mL
- •Must have been previously treated with at least 60 cGy of external beam radiotherapy or brachytherapy for clinical stages T1-2NXM0 with PSA no greater than 30 ng/mL
- •No metastatic disease at time of biopsy
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •CALGB (Zubrod) 0-1
- •Life expectancy:
- •At least 5-10 years
- •No other "currently Temporarily closed" malignancy except nonmelanoma skin cancer
- •Patients are not considered to have a "currently Temporarily closed" malignancy if they have completed therapy and are considered to be at less than 30% risk of relapse
- •PRIOR CONCURRENT THERAPY:
- •Endocrine therapy:
- •At least 3 months since prior adjuvant hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 18 months since prior external beam or interstitial radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Surgery
Salvage prostatectomy
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Survival characteristics
时间窗: pre treatment; q 3 mon for 2 years, then q 6 mon for 2 yrs, then q year
次要结局
- QOL assessment(pre treatment; 3, 6, 12, 18, and 24 mon post treatment)